• Participate in the implementation, development, management and integration of the Bionano Genomics QMS.
• Serve as a Quality Systems resource for problem identification, CAPA and reporting.
• Review and release quality records (including manufacturing batch records, work instructions and other related documents) for each production lot.
• Participate in the design, release and implementation of documentation for process control, process improvement, inspection and test.
• Implement and maintain metrics (first pass yield, process capability and control charts) for management review and monitoring system effectiveness.
• Perform root-cause analysis and implement corrective action to drive process improvements.
• Maintain collection and analysis systems of statistical data to predict trends that will improve product quality.
• Assist in product and process validation activities.
• Report to management on quality issues, trends, and yields.
• Participate in internal and external quality audits.
• Interface with suppliers regarding supplier performance and ensure that effective corrective action is implemented.
• Assist in Document Control activities and Change Control Board meetings.

Skills: QMS Management, CAPA Analysis, Document Review, Process Improvement, SPC Metrics, Validation Support, Audit Compliance, Supplier Quality

• Independently budgets daily work schedule to carry out assigned duties that support business goals.
• Interact constructively with globally based employees, managers and cross-functional peers.
• Complete tasks, create compliant documentation and records, and provide solutions to problems of low to medium complexity.
• Support project work and act as a community member.
• Ensure compliance with site-level policies and procedures.
• Be in charge of right-first-time focus and an eye for detail to ensure the records generated are accurate.
• Receive general direction and execute tasks to completion.
• Develop possible solutions to obstacles.
• Review data sources and records, identify GAPs and follow leads to investigate solutions.
• Help to provide GAP analysis, data sets and justifications in support of change.
• Use the global and local networks to execute changes.

Skills: Work Scheduling, Global Collaboration, Documentation Compliance, Detail Focus, Task Execution, Problem Solving, Data Review, Change Execution

• Ensure that quality system requirements are established and maintained according to the FDA’s 21 CFR 820.
• Report the performance of the quality system to management with executive responsibility.
• Perform inspections of the quality attributes of Pajunk products according to written SOPs and Work Instructions (WIs).
• Comply with all company policies, procedures, work instructions and training requirements.
• Perform inspection of incoming raw materials according to established specifications.
• Tag all non-conforming material and place it in quarantine.
• Perform in-process inspections and labeling and packaging inspections of Pajunk convenience trays as specified in the appropriate SOPs and WIs.
• Inspect all returned products to ensure product quality is not compromised and the product is in good, re-sellable condition.
• Interact with production and warehouse personnel to ensure quality, packaging, and documentation requirements are met.
• Escalate issues to the Quality and Regulatory Manager.
• Maintain, control, and distribute controlled documents and records related to the Pajunk Quality Management System.
• Assist with monthly and quarterly monitoring of the cleanroom and warehouse.
• Document and maintain records of all quality activities as required by the Pajunk Quality Management System.

Skills: QMS Compliance, Quality Reporting, Product Inspection, Policy Adherence, Material Inspection, Nonconformance Handling, Documentation Control, Cleanroom Monitoring

• Review/coordinate consumer complaints.
• Support the GMP training program to ensure compliance with CFR 21 regulations.
• Coordinate/revise/manage QA SOPs and product specifications.
• Document and coordinate product risk assessments to assure compliance with Quality System requirements.
• Collect and publish quality and compliance metrics and report trends to management.
• Coordinate, assess change control, investigations, and deviations.
• Coordinate SDS change control and distribution.
• Track and oversee document management to ensure quality compliance.
• Process and assess product samples.
• Assure that analytical test methods, specifications are met.
• Support internal quality improvement initiatives.

Skills: Complaint Handling, GMP Training, SOP Management, Risk Assessment, Quality Metrics, Change Control, Document Management, Sample Testing

• Responsible for being the SME for ERP systems in relation to Q&C processes within HMD CQ EMEA, stop shipment, traceability, expiry date and batch release.
• Get energized by the shop floor quality issue investigations, connections with operations and stimulating the identification of the real root cause and preventive actions in order to avoid recurrence.
• Act as Quality Assurance representative within the different warehouse teams and support the Operations of the European Distribution Center (DC Courcelles) in Good Distribution Practices in the warehouse.
• Improve the processes by assisting/leading CAPA plans and supporting continuous improvements from a quality perspective.
• Share expertise by training and qualifying relevant stakeholders and operators.
• Evaluate and ensure proper documentation of applicable quality records and approve accordingly.
• Expand knowledge by supporting and/or executing internal and external audits.
• Develop a thorough understanding of the distribution processes and become an SME on root cause analysis, risk assessment, and delivery service issue management.
• Join the GMP field by reviewing and analyzing batches (eg, rework) and assisting the team by maintaining the quality system.
• Broaden the network by involvement in all hospital medical devices.
• Get inspired and activated by the supporting project team activities and guide them towards compliant project execution.
• Strengthen the team by driving the digitalization and efficiency through proposing process improvements.

Skills: ERP Quality SME, Root Cause Analysis, QA Warehouse Support, CAPA Management, Stakeholder Training, Record Evaluation, Audit Support, Process Improvement

• Ensure compliance of Baxter procedures with the relevant standards and update procedures.
• Provide quality insight, assessment and approval to product and process changes to ensure compliance and keep safe and effective Drugs and Medical Devices on the market.
• Provide support for New Product Development and guide teams through the development process to ensure compliance with quality systems.
• Utilize DMAIC tools to promote structured non-conformance investigation and participate in corrective and preventive actions (CAPA) related activities.
• Lead a team through the quality planning and execution of projects.
• Support Quality internal and external audits.
• Serve as an internal auditor.

Skills: Procedure Compliance, Change Assessment, NPD Support, DMAIC Investigation, CAPA Support, Project Leadership, Audit Support, Internal Auditing

• Review the change control projects and provide the quality approvals for them.
• Share the change control metrics with the departments.
• Organize follow-up meetings with change control project owners and department managers.
• Coordinate the CCB meeting and generate meeting minute notes.
• Perform impact assessment.
• Conduct in-depth complaint investigations.
• Approve the complaint evaluation conclusion documents.
• Participate in compliance risk evaluation meetings and distribute the meeting notes.
• Implement or maintain quality systems, procedures and standards.
• Understand and assure conformance to regulations and company procedures.
• Support internal and external audits.
• Identify and manage continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
• Initiate nonconformance reports and be involved in the investigation.
• Responsible for coaching, training and development of subordinates in change control and as a master trainer.

Skills: Change Control Review, Metrics Reporting, Meeting Coordination, Impact Assessment, Complaint Investigation, Risk Evaluation, Quality Systems, Continuous Improvement

• Administer the Document control system.
• Update or write new SOPs and complete the chain of approval for document review.
• Responsible for scheduling and carrying out the quality-related training program for new hires and the team.
• Maintain, track and ensure completion of personnel documentation for the clinical laboratory, including Competency Assessments, new hire onboarding documentation, training, licensure and qualifications.
• Responsible for maintaining signature logs.
• Track licensure status for the laboratory, submit and file renewals, new licensures and changes.
• Present the status of personnel documentation and licensure at quality review meetings.
• Maintain, update and deliver training content on Overview of Quality, GDP, Incident Reporting, as well as adding new modules.
• Participate and support other quality team initiatives and ongoing activities such as reagent qualification, instrumentation validation and batch record reviews.
• Participate and support internal audits and external audits from regulatory bodies or customers/partners.

Skills: Document Control, SOP Management, Training Coordination, Personnel Documentation, Licensure Tracking, Quality Training Delivery, Validation Support, Audit Support

• Perform ongoing formal testing of completed KYC records to ensure standards are met.
• Interpret and apply the Global KYC Standards, guidelines, and QA policies and procedures.
• Accountable for questioning and investigating the reliability and integrity of data, the validity of conclusions and the appropriateness of assumptions made.
• Identify key issues, risks, trends, observations and provide reporting of results to key stakeholders.
• Perform root cause analysis and make recommendations for addressing identified deficiencies or improvements to business processes.
• Present findings via a formalized feedback loop process, track and monitor corrections to identified critical defects.
• Present complex and sensitive issues to senior management in a persuasive manner.
• Work with Global Partners to ensure consistency with the Global QA framework and governance approach.
• Consider regulatory requirements and best practices to implement changes to the process.
• Effectively communicate with key points of contact to ensure the fluid sharing of information and feedback across pertinent teams.
• Maintain the highest level of confidentiality throughout the QA process, disclosing only pertinent information to key stakeholders.

Skills: KYC Testing, Standards Interpretation, Data Integrity Review, Risk Reporting, Root Cause Analysis, Feedback Management, Stakeholder Communication, Regulatory Alignment

• Generate and maintain the site Validation Master Plan.
• Generate Validation Change Controls and complete Change actions assigned by others.
• Generate validation documents, including schedule, plans, protocols, reports and exceptions, liaising with other functions.
• Organise and Co-ordinating Process Validation Campaigns, including coordination with clients.
• Coordinate with other support functions (internal and inter-company) for all Validation activities, e.g, Quality, Operations, QC Laboratories and Supply Chain.
• Write or amend Batch Manufacturing Records when directly related to Validation activities for existing products.
• Review Process and Analytical Development reports and other supporting documentation relating to the new Products, or changes to existing products and assessing their suitability for Validation.
• Review commercial products to ensure Continuation of Validated Processes through Continuous Process Validation (CPV) and contribute to Quality Annual Reviews (QARs).
• Provide technical/validation guidance in the assessment of process deviations with respect to equipment performance and impact on product quality.
• Participate in Equipment Validations, e.g., Temperature Mapping of Operations equipment.
• Participate in Validation History Reviews for systems to ensure validation practices are in compliance with the most up-to-date regulatory requirements.

Skills: Validation Planning, Change Control, Document Generation, Process Validation, Cross-Functional Coordination, Batch Record Support, CPV Review, Technical Guidance

• Responsible for driving overall quality performance throughout the supply chain.
• Schedule and lead a team through the planning and execution of projects or a defined piece of a larger project.
• Construct detailed, accurate project schedules, interfacing with development groups and technical support groups.
• Develop and execute IQ, OQ and PQ protocols for product, processes and equipment within the facility.
• Write reports summarizing results and statistics for all equipment, product, or process validation projects.
• Review existing validation reports and identify gaps for GMP compliance.
• Develop strategies and plans to close the gaps in an efficient and technical manner.
• Participate as an active member in the new product development team and be the Subject Matter Expert for verification and validation activities.
• Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
• Provide day-to-day support to engineering and manufacturing for verification, validation, design control, test method validation and design transfer activities.
• Mentor others and provide guidance and technical expertise on regulatory and Baxter requirements in validation strategies and processes.
• Assess the impact of changes to current Good Manufacturing Practices (cGMP) equipment and systems.
• Review and/or approve documentation (Project Plans, Validation protocols, standard operating procedures, etc).
• Conduct process and component validations.
• Guide peers in the use of statistically-based Quality Engineering approaches in project and test planning and in the analysis and interpretation of test results (e.g., FMEA, DOE, SPC, etc.)
• Supervise/coordinate an engineer and/or technicians on assigned work.
• Support or lead failure investigations and root cause analyses relative to validation failures.
• Devise new approaches to complex problems through adaptations and modifications of standard technical principles.

Skills: Quality Performance, Project Leadership, Validation Protocols, Report Writing, GMP Gap Review, NPD Support, CAPA Execution, Technical Guidance

• Develop and execute manual and automated tests to ensure functional requirements are satisfied.
• Test strategy design, planning, test case design and Data Creation.
• Work with Engineers to drive improvements in overall quality, automation and testing processes and practices.
• Conduct regression tests, integration API tests and UI tests, extend to include coverage for new functionality and Selenium scripts execution.
• Analyze problems and trace the root cause of a failure or problem, being able to provide a comprehensive explanation of how to recreate the problem and how the root cause was identified.
• Stay abreast of the latest developments in technology and industry best practices and identify where they can be incorporated to bring continual improvement to the testing process and tooling.
• Collaborate and communicate effectively with team members and other teams.
• Collaborate with teams across geographies.

Skills: Manual Testing, Automation Testing, Test Strategy, Quality Improvement, Regression Testing, Root Cause Analysis, Continuous Improvement, Team Collaboration

• Review and approve forms related to routine activities such as incoming inspection of raw materials, facility cleaning and preventative maintenance of equipment.
• Review and approve Standard Operating Procedures (SOP).
• Review and approve quality events, including non-conformances, change control and corrective/preventative actions.
• Maintain, organize and archive documents including manufacturing packages, SOP’s and executed job records.
• Review and approve manufacturing packages used for production, including blueprints, routing sheets, and inspection logs.
• Coordinate the initiation/revision of manufacturing packages with the engineering department.
• Release manufacturing packages for production based on client purchase orders.
• Review and approve executed manufacturing packages to ensure the product was manufactured in accordance with blueprints and applicable SOPs.
• Generate Certificates of Compliance (CofC), release product labels and authorize the release of client product.
• Coordinate production and testing associated with quarterly dose audits per ISO 11137-2.
• Assist the Quality Assurance Manager with the maintenance of the Quality System.

Skills: Form Approval, SOP Review, Quality Event Review, Document Control, Package Review, Engineering Coordination, Product Release, Quality System Support

• Ensure compliance with Federal Regulations, ICH Guidelines, Standard Operating Procedures (SOPs), and company policies.
• Perform quality review of client submissions and study-related documents for accuracy and compliance with applicable regulations and standard operating procedures.
• Perform study file audits in support of client submissions to determine accuracy and compliance with applicable regulations and standard operating procedures.
• Communicate effectively with clients to identify and promptly resolve issues related to submitted documents.
• Communicate effectively with team members to promptly resolve issues related to the quality of documents.
• Provide procedural guidance related to the submission of study documents to clients and team members.
• Actively contributes to and assists with continuous quality improvement and other quality initiatives.
• Contribute ideas and suggestions to the leadership team for improvement to enhance services or processes, both for internal and client value.
• Assist with periodic audits of study files.
• Assist with the file verification of regulatory documents.
• Assist with the compilation and reporting of quality-related metrics to management.
• Attend educational conferences.

Skills: Compliance Review, Document Audit, Client Communication, Team Collaboration, Procedural Guidance, Quality Improvement, Metrics Reporting, Regulatory Support

• Monitor the laboratory quality system to ensure quality throughout.
• Monitor quality standards compared with established targets.
• Halt laboratory processes out of control or for non-conforming events and report.
• Participate in the lab’s quarterly audits based on ISO 17025 policies.
• Ensure deficiencies are corrected in compliance with all policies.
• Perform batch reviews and upload documents into Amazon Work Docs for client sample results.
• Review laboratory activity logs/forms conducted during the week that are not part of the weekly batch.
• Perform monthly reviews of the Master Equipment List to verify that all equipment is calibrated.
• Perform spot checks of preventative maintenance to confirm completion at the appropriate time.
• Review Quality and Results Sheets to confirm all system suitability checks have passed prior to reporting client data.
• Conduct annual reviews of training, standard operating procedures, including updates or new documents.
• Review, approve and track Corrective and Preventive Actions.
• Perform annual evaluations of approved vendors to ensure the quality and performance of the vendor is satisfactory.
• Accountable for evaluation includes quality performance, on-time delivery, pricing, and responsiveness/cooperation in addressing the lab’s needs.
• Complete weekly laboratory walk-through to ensure day-to-day operations follow ISO 17025 policies.
• Participate in state, other audits, and data integrity investigations.

Skills: Quality System Monitoring, Audit Participation, Batch Review, Equipment Verification, Maintenance Checks, Data Verification, CAPA Management, Vendor Evaluation

• Administer QC laboratory electronic systems, electronic QMS.
• Provide ongoing operation, maintenance and implementation of improvements to electronic systems.
• Support the Management of the relationships with external system providers for technical and helpdesk support.
• Ensure procedures are in place for backup of data on electronic systems.
• Ensure retrieval of data from archived systems is tested.
• Generate, review and approve qualification documentation for electronic systems in line with procedures.
• Support the Implementation of system upgrades and new software applications.

Skills: Electronic QMS Admin, System Maintenance, Vendor Support, Data Backup Control, Data Retrieval Testing, Qualification Documentation, System Upgrades, Software Implementation

• Ensure that Vaccine products and services are in compliance with corporate directives, GxP and local requirements.
• Manage the national lot release application.
• Responsible for managing batch release.
• Responsible for package materials review.
• Support change control, risk management and recalls.
• Perform/Support self-inspection, regulatory inspection and CAPAs.
• Support Annual Quality Review and Product Review.
• Support ensuring Analytical Method Transfer.
• Back-up qualified person for batch release and Imported W/H management.
• Support a qualified person’s role in his vacant position for urgent release.
• Manage goods receipt, cold chain, and the National lot release application and its sampling.
• Prepare and obtain approval of the summary protocol of imported products to submit to the Korean Health Authority.
• Manage products' technical complaints (PTC) concerning products manufactured and distributed by Sanofi sites or subcontractors.
• Manage PTC Management of cold-chain breaks.
• Support for the distribution center to ensure that GSP/GMP is implemented in the warehouse.
• Support the manager to make usage decisions and salvage defective products.
• Manage KGSP documents and required regulatory dossiers.
• Ensure that products are manufactured, imported, or distributed appropriately according to quality requirements.
• Support the assessment of subcontractors’ KPI.
• Support the management of deviation, event, and change control of quality documents from manufacturing sites and distributors.
• Document archiving and management for imported products.
• Support the management of Quality Documents.
• Support periodic revision of affiliate QDs (SOP, SD, etc), and their operation.
• Archive electronic GxP records in the GxP archiving tool.

Skills: Quality Compliance, Batch Release, Packaging Review, Change Control, Audit Support, Complaint Management, Cold Chain Oversight, Document Management

• Create documentation for best practices, PMO tools, templates, policies and standard operating procedures.
• Serve as an advisor to the internal LTS team on an ongoing basis, whilst supporting strategic priorities and managing expectations.
• Support the collection of performance metrics for the LTS scorecard process.
• Prepare reports and maintain project documents.
• Own and drive areas of a project with the ability to find redundancies between dependencies, plan for next steps and be able to multitask across multiple deliverables.
• Create and build reporting and slides for status update presentations.
• Maintain and manage existing documentation in the LTS file repository and other various trackers.

Skills: Documentation Development, PMO Support, Metrics Tracking, Report Preparation, Project Coordination, Status Reporting, File Management, Strategic Advising

• Manage/oversee Product Complaint Intake, including follow-up with customers, Corporate Product Complaints and other third parties.
• Coordinate product complaint returns.
• Notify customers of complaint closure.
• Identify Adverse Events, Medical Information enquiries and potential falsified medicines.
• Deliver training to personnel on Quality-related activities, including maintaining training assignments, training records and assisting with training material development.
• Maintain Key Performance Indicators (KPis) for Quality-related activities.
• Assist with Quality-related enquiries from internal staff, external customers and Regulatory Authorities.
• Support Deviations, CAPAs (Corrective/Preventive Actions) and CAPA-EV (effectiveness verification) for Quality issues.
• Assist with self-assessments, internal audits and Regulatory Authority inspections.
• Assist during mock recall activities.
• Author, edit and update GMP/GDP documents in the controlled document management system.
• Manage/support the customer re-approval process.
• Ensure accurate general record-keeping.
• Become acquainted, maintain and use Quality systems, databases and other relevant data collection.
• Perform Temperature assessments as a Temperature Excursion assessor for the European region, ensuring all procedural requirements are met.
• Recognize and escalate problems.
• Apply research, information gathering, analytical and interpretation skills to problems of diverse scope.
• Ensure compliance within the regulatory environment.
• Develop solutions to problems of moderate complexity.
• Screen, categorize, evaluate, reconcile, report and resolve data integrity issues.
• Interpret generally defined practices and methods.
• Provide technical support in the maintenance of the affiliate QMS within BENELUX in alignment with GMP/GDP regulations and applicable standards, policies and procedures.
• Act as an interface with customers and staff for quality-related issues.
• Facilitate the effective working relationships between International Distribution and Quality and other groups.
• Set project timeframes and priorities based on project objectives and ongoing assignments.

Skills: Complaint Management, Adverse Event Identification, Quality Training, KPI Tracking, CAPA Support, Document Control, Temperature Assessment, QMS Support

• Support and instill a culture of quality within Orpyx.
• Attend weekly quality meetings, including setting the agenda, monitoring the status and progress of key issues, actions and commitments and keeping the Quality Manager informed of key updates.
• Support the communication and resolution of quality management issues within Orpyx.
• Create, track and maintain QMS-related tickets using the company’s software tools.
• Provide guidance and support to departments within Orpyx regarding QMS-related issues.
• Support the preparation and updating of QMS documentation, including work instructions, Standard Operating Procedures (SOPs) and reference documents.
• Work within the Orpyx eQMS (Greenlight Guru) to maintain and update quality-related documentation.
• Maintain Orpyx’s QMS to ensure compliance with ISO 13485, US FDA Title 21 CFR 820, Health Canada Canadian Medical Device Regulations (CMDR).
• Manage and oversee the preparation for and participation in internal and vendor-initiated audits.
• Support the Quality Manager in the preparation for and participation in external audits.
• Establish, execute and report on the internal audit program and follow up on action items and commitments.
• Provide support to Sales, Marketing and Operations in the event of a regulatory notification and/or product recall.
• Develop content and provide training on quality management objectives, processes and responsibilities.
• Maintain a clean and safe working environment.
• Perform duties in a manner that is consistent with and committed to upholding the requirements of the quality management system.

Skills: Quality Culture Support, QMS Ticketing, Documentation Management, Regulatory Compliance, Audit Management, Issue Resolution, Quality Training, Cross-Functional Support

• Support the development and maintenance of quality procedures and systems related to Quality Assurance oversight.
• Assist with processing, vendor GDP certifications, change Controls and other Quality documentation utilizing Marken's qualified document control system, ZenQMS.
• Supports the development of quality systems for QA oversight of CTD and Logistic processes.
• Support generation and control of standard operating procedures (SOPs) and supplemental documents.
• Assist with training personnel on quality systems, processes, and procedures.
• Acquire and maintain knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance-related matters are provided to the site.
• Assist with continuous improvement.

Skills: Quality System Support, Documentation Control, GDP Certification Support, SOP Management, Quality Training, Regulatory Knowledge, QA Oversight, Continuous Improvement

• Work with the Kitchens Site Launch Team to assess new box readiness.
• Work with the Training and Operations Team to establish standards of excellence within all REEF boxes.
• Assess the standards of excellence within a new box.
• Feedback to the Kitchen Site Launch Team to ensure operational holes are addressed.
• Accountable for initial brand assessments.
• Work with the Brand Success Team and the Training team to assess new brands across all sites, REEF-Operated and Asset Light.
• Work with the Training and Culinary Team to establish standards of excellence across all brands.
• Assess the standards of excellence across all brands.
• Feedback to the Training and Operations teams to ensure operational holes are addressed.
• Conduct routine inspections of sites (both REEF-run and Asset-light) for operational conformity.
• Conduct routine food assessments, through ordering and through on-site inspections, of all brands across all sites.
• Develop and grow the mystery shopper network and conduct reviews through said service.
• Feedback to senior management about all aspects of operational and brand quality.

Skills: Site Readiness, Standards Assessment, Brand Evaluation, Operational Feedback, Routine Inspections, Food Quality Checks, Mystery Shopper Management, Quality Reporting

• Complete the required number of quality assurance audits and quality-related tasks.
• Report to the management team identified error trends and QA metrics.
• Provide team coaching and 1 2 1 sessions to improve knowledge, skills and performance.
• Participate in root cause and other data analysis for the regional and global delivery centre.
• Work closely with the other QAs to provide problem prevention solutions and continuous improvement projects.
• Identify improvement opportunities within the CDS Operation.
• Monitor and measure the team's quality performance against defined criteria as part of the quality framework.
• Work closely with the training team to highlight quality and performance areas for focus, to feed into their training program.
• Participate in calibration exercises with the other regional QAs.
• Responsible for continuous improvement strategies and ideas, including new process incubation and induction.
• Consistently drive quality and best practices at the highest level within the region and across regions.

Skills: Quality Auditing, QA Reporting, Team Coaching, Root Cause Analysis, Continuous Improvement, Performance Monitoring, Training Support, Quality Calibration

• Responsible for evaluating quality indicators and performing trending analysis by means of appropriate statistical tools.
• Responsible for complaint documentation, investigations and identification of potential adverse events and potentially reportable events.
• Maintain and update all product codes within the systems.
• Resolve discrepancies received from the manufacturing plants.
• Establish measurements within areas of responsibility to reach and maintain the Facility’s goals.
• Ensure that actions related to non-compliance investigations of the area of responsibility are completed on time and their effectiveness is measured.
• Responsible for monitoring, updating and maintaining the quality metrics assigned as per the area of ownership, submitting them to management for review and action determination.
• Maintain the systems WMS (dimensions, pallets stack high and weight).
• Responsible for informing of unsafe behaviors and recommending safety measures to the appropriate department.
• Serve as backup in specific inventory control functions.
• Provide support to Internal Audits and Training Quality Systems.

Skills: Quality Trending, Complaint Handling, Code Maintenance, Issue Resolution, Performance Measurement, Noncompliance Actions, Metrics Monitoring, Audit Support

• Manage operations risk projects within aligned functions, assess business risks and work with the Operations teams to ensure adequate detective and preventative controls are in place to mitigate risk.
• Work with Operations Risk Managers in significant efforts, including but not limited to audit management and information gathering, analyzing and validating lending documentation and processes, and oversight of risk projects.
• Represent Risk as subject matter expert on cross-functional operational risk initiatives/projects.
• Manage or participate in various stages of the CORE Control cycle, including performing control tests and validating test strategies.
• Manage and report status for internal compliance reviews and internal audits.
• Manage tasks related to Action Plans, including analyzing solutions, proposing plan descriptions, overseeing plan tasks, validating work, and managing approvals and closure.
• Engage in root cause analysis and work with the appropriate groups to recommend controls and solutions when researching risk events, operational processes, and new regulatory initiatives.
• Manage risk events and risk action items to closure.
• Validate compliance of action plans, audit findings, and new regulatory initiatives.
• Create, support, and manage various regulatory and risk reports.
• Facilitate meetings, prepare documentation and minutes.
• Effectively communicate with all levels of management and work across business lines.

Skills: Risk Project Management, Control Assessment, Audit Support, Control Testing, Action Plan Management, Root Cause Analysis, Regulatory Reporting, Cross-Functional Communication

• Review important documents, records, and reports, such a Manufacturing Formulation Records (MFRs), Manufacturing batch Records (MBRs), against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines.
• Identify areas of nonconformance and escalate to management (Manufacturing and Quality) for initiation of a Deviation.
• Perform initial investigative actions on Deviations (minor and no patient risk), applying well-established techniques and procedures.
• Administer and maintain relevant databases, prepare and issue reports as defined by the area.
• Support external and internal audits by maintaining audit records, extracting data from databases, and creating reports, and collecting relevant data.
• Revise or review standard operating procedures (SOPs) to support Division Procedure Compliance or continuous improvement efforts.
• Maintain departmental business indicators and prepare metrics for the Management Review of Quality Systems.
• Responsible for audit/review documents for completeness, cGMPs, company procedures and verification of data.
• Apply problem-solving tools and methods to lead investigation teams.
• Apply knowledge of FDA Regulations and application of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

Skills: Document Review, Deviation Management, Initial Investigation, Database Administration, Audit Support, SOP Management, Metrics Preparation, GMP Compliance

• Oversee all technology components of diverse, complex automation projects, including project planning, execution, timing, functionality, quality and cost.
• Communicate with end-users to provide timely and accurate information and status updates.
• Responsible for budget, policy formulation and planning.
• Contribute to the formulation of strategies for project leadership and other functional areas.
• Evaluate subordinates' performance and make decisions on pay increases, hiring, terminations and other personnel actions.
• Apply in-depth understanding of concepts and procedures within own area and basic knowledge of other areas to resolve issues that have an impact beyond own area.
• Demonstrate a comprehensive understanding of how areas of IT project leadership collectively integrate to contribute to achieving business goals.
• Provide evaluative judgment based on analysis of factual information in complicated and unique situations.
• Directly impacts the IT project leadership area through responsibility for the delivery of end results and shared responsibility for budget management, accountable for resource planning.
• Ensure essential procedures are followed and contribute to defining standards.
• Persuade and influence others through communication and diplomacy skills, and may negotiate with external parties.
• Understand data structures, have market data knowledge and understanding of various vendors, e.g., Bloomberg, Reuters, IDC.
• Analyse data automation and validation across 5 LOBs, 10 LEs, and over 100 critical applications.
• Analyse, consume, map, model, visualize, store, maintain, report and leverage data using technology (and smart tools).
• Attend to the production of metrics, KPI and analysis to assist the team in making data-driven automation decisions.
• Design and implement an effective, best-of-breed solution to automate, capture, collate, store and maintain real-time test data for the purpose of validation, measuring progress and performance in change delivery.
• Define and implement a data validation approach to ensure data solutions comply with internal and external regulations/standards and monitor data integrity, standard and consistency through iterative testing, especially where new features are being integrated.
• Own datasets for automation testing and those provided/used by vendors to test.
• Define runbooks for data migration from legacy sources to new solutions.

Skills: Automation Project Leadership, Stakeholder Communication, Budget Management, Strategy Development, Team Management, Data Analysis, Data Validation, Solution Design

• Perform quality audits of Work Authorization team processes and data for accuracy and integrity.
• Identify root case defects, analyzing audit data to identify patterns and trends.
• Track, measure and report quality metrics at different intervals to ascertain the process performance health and identify improvement areas.
• Responsible for providing deep dive research and analysis of escalations.
• Coordinate with the internal team resources of compliance, audit and quality, and delivery to ensure high standards for a frustration-free experience.
• Demonstrate the highest degree of discretion and confidentiality.

Skills: Quality Auditing, Root Cause Analysis, Metrics Reporting, Escalation Analysis, Cross-Team Coordination, Data Integrity Review, Process Improvement, Confidentiality Handling

• Act safely, know, and follow all EH&S safety requirements for the site.
• Display knowledge in cGXP, materials, components, and supplier management.
• Excellent written and verbal communication and interpersonal skills.
• Organize oneself and track the status of assigned actions across multiple products.
• Organize and provide written and/or oral presentations of work with minimal input.
• Provide support for QA material enrollment and supplier qualification activities.
• Identify and implement new processes and programs for quality improvement.
• Contribute to the interpretation of cGXPs for the commercial and clinical environment.
• Independently reviews working instructions/global procedures for technical content across multiple subject areas.
• Interface with other parts of the organization, such as research and development groups.
• Work outside the immediate subject area, supporting a wider range of customers of differing subject areas and locations.
• Develop the ability to train other team members on tasks.
• Resolve complex issues with minimal assistance from management.
• Represent Quality Assurance in cross-departmental/cross-site/cross-network meetings.

Skills: Safety Compliance, Supplier Management, Communication Skills, Action Tracking, QA Support, Process Improvement, cGXP Interpretation, Cross-Functional Collaboration

• Review Batch records, deviations, investigations, documents, validation protocols, and reports for compliance with internal and GMP standards.
• Maintain and monitor key quality systems such as deviations, investigations, and CAPA, which includes the review of trended data to identify areas for improvement.
• Conduct system and GMP training.
• Represent the department during client audits and FDA inspections.
• Write and revise Standard Operating Procedures (SOPs).
• Provide guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities.
• Interact with personnel from all departments of Johnson Matthey to ensure GMP compliance.
• Recommend the stop of manufacture and/or distribution of the product.
• Review Master documents such as In-process forms and Batch Records.
• Approve stability study protocols, validation documents, test methods, and reference standards.
• Interact with contractor personnel regarding validation and qualification activities.
• Assist in the scheduling and maintenance of Quality Assurance activities and systems.

Skills: Batch Record Review, Quality Systems Monitoring, GMP Training, Audit Representation, SOP Management, QA Staff Guidance, Cross-Functional Compliance, Validation Support

• Ensure that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.
• Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs, WIs, etc.)
• Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.
• Perform raw material inspections and raw material release according to SOPs and in compliance with all regulatory standards.
• Issue batch records, review of media batch records.
• Issue and maintain all cGMP and cGTP documentation, including but not limited to logbooks, training binders.
• Perform Accessioning of incoming Apheresis.

Skills: Quality Compliance, Procedure Adherence, Material Inspection, Batch Record Review, Documentation Control, Raw Material Release, Apheresis Accessioning, Regulatory Alignment

• Compile data for local and regional reporting and notification of critical quality events to Senior Management, internal and external stakeholders.
• Support the internal audit program by performing scheduled audits of the sites’ GxP departments.
• Support the front room/back rooms during audits of sites.
• Manage the end-to-end Product Quality.
• Complaint processes, including but not limited to investigation, trending and generating/presenting complaints data to internal and external stakeholders.
• Ensure regional and site SOPs are maintained by managing site SOP review schedules, initiating workflows, providing QUMAS application support and collaborating with departments on their procedural documents needs.
• Maintain a system for issuance, reconciliation and archival of technical document numbers.
• Track, trend and report timely closure of site quality systems events.
• Manage the Supplier Quality Performance program by creating appropriate templates for supplier data input, compilation of risk scores and risk classification.
• Monitor and assess supplier regulatory inspection results, perform regular surveillance of updates/changes to regulatory law/guidance and assess impact to systems, processes and procedures.
• Maintain (create, edit, obsolete) Material Master Data in SAP for products managed by the Third Party Quality Group.
• Support implementation and continuous improvement of GxP IT systems and processes that support regulatory compliance and business needs.
• Provide support to the quality and compliance oversight of 3PLs.

Skills: Quality Event Reporting, Audit Support, Product Quality Management, Complaint Handling, SOP Management, Document Control, Supplier Quality, Master Data Maintenance

• Support Analytical Method Transfer (including Bio Assay) to the Korean contract Lab.
• Implement and support product sample delivery from the Korea warehouse to the contract lab.
• Manage local contract lab and warehouse (day-to-day testing/communication, KPI, etc.)
• Support and implement reagent, reference standard and samples importation to Korea, including communication with the broker and shipper.
• Support and manage quality document filing.
• Support documentation for batch disposition, product complaint, annual product review, QMS, etc.
• Support quality regulatory inspection.
• Support product complaint handling.

Skills: Analytical Transfer Support, Sample Logistics, Contract Lab Management, Import Coordination, Document Filing, Batch Documentation, Regulatory Support, Complaint Handling

• Manage the resources for the internal and sponsor audit program and ensure audits are conducted according to QA procedures.
• Audit includes, but is not limited to, internal audits, sponsor audits, and effectiveness checks.
• Discuss critical issues with operational departments to ensure appropriate resolution.
• Responsible for revising QA procedures.
• Manage the delivery and retrieval of QA documentation during sponsor or regulatory audits/inspections.
• Train junior members of the QA team.

Skills: Audit Management, Effectiveness Checks, Issue Resolution, Procedure Revision, Document Handling, Regulatory Support, QA Training, Cross-Department Coordination

• Issue batch documentation to manufacturing.
• Perform final review of batch and/or critical systems documentation and determine acceptability by using standard operating procedures.
• Ensure the presence and acceptability of all required documentation prior to the release of the product and/or system.
• Support the day-to-day management of the batch release process.
• Review documentation such as protocols, CWRs, qualifications, etc.
• Compile certificates of analysis.
• Enter data into JDEdwards.
• Generate reports from Trackwise 8.
• Support annual product quality reviews and quarterly FDA reports.
• Assist the facility in preparation for quality audits and participate in corporate audits and external inspections.
• Own and support nonconformance investigations specific to QA Release processes.
• Identify opportunities for continuous improvement, lead projects and implement continuous improvement initiatives.
• Communicate proactively with internal and external partners and management.
• Maintain files such that documents are readily available and easily retrievable.
• Train and mentor less-experienced quality department employees.
• Assist the department with monthly/quarterly Quality System data review metrics and reporting.
• Cross-train and learn different positions in QA, such as training and QA Technician roles, to fill in during vacations, leaves, and “all-hands-on-deck” situations.
• Collaborate within and outside the department on special projects, including moving various programs and paper-based documents to electronic formats.

Skills: Batch Documentation, Final Review, Batch Release Support, Protocol Review, COA Compilation, Data Entry, Audit Preparation, Continuous Improvement

• Work in a fast-paced, team-oriented environment, in which they will be responsible for completing various tasks to ensure the quality of the product meets required standards.
• Collect and prepare rubber and tire component samples for testing.
• Build of certain components for specialized testing.
• Communicate atypical results to managers, engineers, and analysts.
• Complete and maintain quality documents.
• Maintain a clean work area through good housekeeping practices.
• Assist in the training of new associates.

Skills: Fast-Paced Work, Sample Preparation, Component Building, Result Communication, Document Maintenance, Housekeeping Practices, Training Support, Product Quality Verification

• Responsible for verifying information prior to shipping.
• Assist with identifying nonconformances.
• Investigate circumstances to establish the root cause and work with others as a team to design and implement the appropriate corrective actions based on root cause analysis.
• Create spreadsheets to capture and track data.
• Create or revise documents.

Skills: Information Verification, Nonconformance Detection, Root Cause Analysis, Corrective Action Support, Data Tracking, Spreadsheet Creation, Document Revision, Team Collaboration

• Analyze quality data from different functions and control quality processes and deviations.
• Audit and review existing Quality Monitoring processes (documents, reports, methods) of each line of Business.
• Interact, ask questions, do deep-dive analysis on evidence and provide feedback to Line Managers.
• Proactively understand business processes and CREATE new Quality Monitoring procedures.
• Provide detailed Root Cause Analysis (RCA) on identified Escalations or Issues.
• Report on a weekly/monthly basis to the Delivery teams and Stakeholders.
• Work under supervision on continuous improvement and optimization of processes, guidelines and tools.
• Work within defined rules and regulations.
• Solve quality issues and provide support on escalations.
• Work as part of the team in quality projects.
• Assist in the preparation of presentation material and prepare documentation.
• Map action items as preventive measures and track the progress of actions.

Skills: Quality Data Analysis, Process Auditing, Deep-Dive Review, Procedure Creation, Root Cause Analysis, Quality Reporting, Continuous Improvement, Action Tracking

• Support day-to-day clinical manufacturing operations from a Quality support perspective (batch record review).
• Perform procedural activities within the Global Documentation Management System.
• Partner with SOP authors to develop procedures and appropriate implementation plans for the management of physical and electronic documents.
• Review SOPs, determine gaps and provide input as it relates to documentation management.
• Perform quality checks of Accounts Payable documents, mostly cost invoices, debit and credit notes.
• Consult identified findings with process owners to clarify the root cause of identified errors.
• Report to management the exceptions identified in a review process on a periodic basis.
• Follow up on identified issues in line with the agreed process to ensure respective correction actions are placed.

Skills: Batch Record Review, Documentation Management, SOP Support, Gap Assessment, Invoice Quality Check, Root Cause Clarification, Exception Reporting, Issue Follow-Up

• Gain an understanding of the application test procedures and how to use applicable software and tools.
• Execute test instructions and report test results accurately and promptly.
• Understand any changes in test instructions related to their assigned work.
• Follow defined processes to perform assigned work.
• Perform batch record and material disposition activities, document review/approval of paper and electronic records.
• Detect, record, and support the resolutions of deviations from established procedures and non-conformances.
• Coordinate document review activities with cross-functional TMs.
• Maintain and retrieve documents and records.

Skills: Application Testing, Test Execution, Process Adherence, Batch Disposition, Document Review, Deviation Handling, Cross-Functional Coordination, Record Maintenance

• NPD and NPI/Transfer to Manufacture experience in the Medical Device or Combination Product fields.
• Experience of submissions to regulatory authorities, including the EU, US and ROW.
• Experience of working within an ISO 13485 quality management system.
• Experience in developing content for Risk Management Files, including Plans, Hazard Assessments, Design FMEA, Process FMEA and Risk Reporting.
• Experience in developing content for Design History and technical files.
• Ability to write technical documents in a methodical and timely manner.
• Willingness to communicate/present to clients at all levels.
• Understanding of current Medical Device and Combination Product regulations.

Qualifications: BS in Chemistry with 7 years of Experience

• Previous experience working in a GxP environment, ideally within a Quality Assurance function and including the distribution of medicinal products.
• Ability to work effectively alone and as part of a team, including remote, international, cross-functional and matrix environments.
• Able to communicate (written and verbal), including presentation and facilitation skills.
• Demonstrated analytical and investigational skills and accurate, timely record-keeping.
• Must have effective organizational and planning skills.
• Excellent standard of written and verbal English and comprehension of written English.
• Good standard of written and verbal Dutch or French language.
• Knowledge of EU regulation relating to medicinal products.
• Experience with Regulatory or third-party inspections/audits.

Qualifications: BS in Biomedical Engineering with 4 years of Experience

• Previous manufacturing experience.
• Previous experience working in a quality-driven environment.
• Must be able to read/comprehend written and oral instructions in English.
• Ability to read and comprehend safety rules, operating and maintenance instructions, procedure manuals and product recipes/materials.
• Ability to perform all Testing SOPs.
• Knowledge and ability to operate all testing equipment and scanners.
• Knowledge of raw materials and finished products.
• Knowledge of Product ID and traceability system.
• Knowledge of customer requirements for finished packages.
• Ability to create a Certificate of Analysis for all products.
• Proven mechanical aptitude with the ability to troubleshoot and fix common problems.
• Self-starter with initiative, attention to detail, and a strong work ethic.
• Able to work within a team environment.
• Must have competency in computer and PC software, including email, internet, and MS Office.

Qualifications: BS in Quality Assurance with 3 years of Experience

• Must have GCP ICH-E6 regulations and ISO 14155, 13485 and 9001 knowledge.
• Knowledge of quality management systems, regulations, and guidelines on medical devices.
• Knowledge of clinical research processes within the medical device industry.
• Must have auditing experience.
• Fluent in English, spoken and written.
• Proficient in the use of computers and software systems.
• Strong attention to detail.
• Good organizational and time management skills.
• Strong interpersonal and communication skills (oral and written).
• Must have proactive and strong problem-solving skills.

Qualifications: BS in Biotechnology with 5 years of Experience

• Experience as a Quality Engineer.
• Technical understanding of JAVA, Selenium and various test automation solutions, with scale infrastructure test frameworks setups, with out-of-the-box thinking.
• Understanding of cloud-enabled data center deployments for SaaS applications.
• Knowledge about development environments and tools like Git, Maven and Jenkins.
• Proficient in at least one of the following automation testing tools: Selenium, Postman and/or any state-of-the-art UI and backend test automation tool, Defect management tools Jira or SAP BCP.

Qualifications: BS in Microbiology with 3 years of Experience

• Good communication skills, both verbal and written.
• Demonstrated ability to work in a team.
• Proficient in MS Office, SQL, and Excel.
• Debugging and troubleshooting skills, with an enthusiastic attitude to support and resolve customer problems.
• Experience working with relational databases.
• Experience with Linux.

Qualifications: BA in Supply Chain Management with 2 years of Experience

• Experience with MS Office and Adobe.
• General knowledge of CAD software (Autodesk Inventor or Solidworks).
• Proficient in interpreting engineering drawings.
• Able to familiarize with both metric and imperial units.
• Working knowledge and application of measuring tools/equipment (Eg, Caliper, micrometer).
• Working knowledge of inspection equipment.
• Must have ASQ Certification.
• Able to print reading and/or GD&T training.
• Must have CMM Operations or knowledge.
• Excellent verbal and written communication skills.
• Must have high Attention to detail.
• Ability to work in a fast-paced team environment.
• Able to manage sensitive and confidential information.
• Must read and write English.

Qualifications: BS in Medical Laboratory Science with 4 years of Experience

• Experience in Quality and regulatory requirements.
• Must have GMP/GDP, Pharma/Biotech, Quality, and regulatory compliance.
• Thorough knowledge of quality systems.
• Must have interpersonal relations skills.
• Customer-focused attention skills.
• Ability to work with little oversight.
• Ability to prioritize and manage multifaceted projects.
• Experience in Quality Assurance and/or in a GMP-regulated environment within the pharmaceutical industry or equivalent.
• Experience with lean, six sigma, issue resolution, etc.

Qualifications: BS in Biotechnology with 5 years of Experience

• Experience in CLIA/CAP laboratories, medical devices, or life sciences industries.
• Working experience with an organization that has an established QMS.
• Must have Document Control experience.
• Excellent interpersonal, verbal, and written communication skills.
• Must have an independent worker, self-starter with strong organizational and planning skills.
• Willingness to accept temporary responsibilities outside of the initial job description.
• Strong familiarity with MediaLab, JIRA, and lab processes.
• Prior experience supporting a fast-paced environment.

Qualifications: BS in Food Science with 3 years of Experience

• Direct and relevant experience in business analysis.
• Working knowledge of industry-accepted standards and best practices related to governance structures, processes, tools, and metrics.
• Ability to execute change management procedures to achieve meaningful change and growth.
• Expert knowledge and ability to communicate effectively in both oral and written forms with all levels of staff, as well as clients.
• Ability to work independently or with limited supervision.
• Possess critical thinking, problem-solving, and initiative/proactive skills.
• Demonstrated working knowledge and understanding of tools such as MS Office Suite.

Qualifications: BS in Environmental Science with 5 years of Experience

• Quality Assurance experience in a cGMP medical device, biotech, or pharmaceutical environment.
• Must have document control experience.
• Strong technical writing ability.
• Knowledge of ISO 13485, QSR (21 CFR Part 820), GLP, GCP, and GMP.
• Strong organizational skills, task-oriented, and excellent time management skills.
• Ability to multitask, flexible and adaptable to changing priorities.
• Able to work well with limited supervision and as part of a team.
• Proven communication skills and ability to negotiate assigned tasks with other departments.

Qualifications: BS in Industrial Engineering with 4 years of Experience

• Manufacturing or quality-related experience.
• Prior experience working in an FDA-regulated environment.
• Demonstrated organizational skills and detail-oriented.
• Basic computer skills (MS Word, MS Excel, MS Outlook).
• Ability to stand for extended periods of time.

Qualifications: BS in Biology with 1 year of Experience

• Advanced inspection and mechanical aptitude.
• Excellent verbal and written English communication skills.
• Must have close attention to detail and the ability to work in a team environment.
• Must be able to manage multiple priorities.
• Advanced Math skills and basic statistics concepts.
• Advanced ability to create Microsoft Excel, PowerPoint and Word documents.
• Excellent interpersonal and customer service skills.
• Able to recognize and communicate potential issues.
• Ability to follow and review department procedures for correctness and write/re-write procedures.
• Able to work well with internal customers from various levels of the organization.
• Able to train others, including “training the trainer”.
• Able to work independently and easily resolve minor daily issues/problems.

Qualifications: BS in Biotechnology with 4 years of Experience

• Related experience in a Warehouse environment.
• Experience in safety, regulated production/GMP, quality, or other related areas.
• Must be computer literate.
• Proficient in Microsoft Office products.
• Experience with an ERP system in a manufacturing environment.
• Must have good communication skills (both verbal and written).
• Must have the ability to work well under pressure.
• Must have bilingual English/Spanish.

Qualifications: BS in Food Science with 3 years of Experience

• Excellent verbal and written communication skills.
• Strong math and analytical skills.
• Must have group facilitation skills.
• Ability to collect, analyze and interpret information and data to arrive at logical conclusions.
• Ability to take general direction and turn ideas and concepts into action.
• Excellent follow-through and administration skills, highly organized, consistent attention to detail.

Qualifications: BA in Supply Chain Management with 2 years of Experience

• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Knowledge of PLEX of other similar ERP manufacturing software, Spreadsheet software, Word Processing software and Internet software.

Qualifications: BS in Chemical Engineering with 3 years of Experience

• Understanding of biologics manufacturing operations.
• Good organizational skills and attention to detail.
• Excellent written, verbal and interpersonal communication skills and the effectively interact cross-functionally.
• Able to handle multiple assignments and changing priorities.
• Able to learn and utilize computerized systems for daily performance of tasks.
• Able to prioritize, manage multiple tasks, and meet deadlines.

Qualifications: BS in Environmental Science with 2 years of Experience

• Experience in the pharmaceutical/combination products industry.
• Strong knowledge of cGxP quality systems, regulations, guidance documents, industry standards and practices.
• Strong familiarity with post-filing and pre-approval activities (validation and commercial readiness).
• Experience in Third Party (CMO) Quality Operations.
• Knowledge of regulations pertaining to combination products and/or medical devices.
• Excellent skills in all areas of communication, collaboration, decision-making, organization, planning, prioritization, time management and technical writing with a close attention to detail.
• Ability to handle multiple projects and meet tight deadlines and timelines.
• Knowledge/experience working with GxP computerized systems.
• Ability to utilize software and customized programs (EQMS, EDMS, and LMS) to meet business needs.
• Proficient in MS Word, Excel, PowerPoint, Vision, and Access.

Qualifications: BS in Chemical Engineering with 7 years of Experience

• Strong computer skills, including Microsoft Word and intermediate Excel skills.
• Exposure to and hands-on experience with a variety of applications.
• Knowledge of documentation systems and familiarity with batch/systems documentation and GDP.
• Must be detail-minded and exact in terms of working with documentation.
• Strong drive to be an independent learner.
• Ability to work with minimal supervision in a dynamic environment while following written procedures.
• Must be organized and able to prioritize tasks.
• Ability to communicate efficiently orally and in writing with all levels of the organization (especially with production supervisors, manufacturing associates and the engineering team) and with external clients.
• Must be flexible, thick-skinned skinned and adaptable to shift gears gracefully through changing priorities.

Qualifications: BS in Biology with 3 years of Experience

• Able to support a broad range of analytical disciplines within the Quality Control laboratory.
• Able to perform testing focused on biochemistry plate and gel-based assays in the QC Analytical Chemistry laboratory.
• Able to perform high-throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision.
• Must follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes.
• Knowledge of gel-based protein separation, IEF, Plate-Based Assays (e.g., SDS-Page, ELISA, Western Blot).
• Able to work with or may take direction from peers within the department, but may work more independently according to the scheduled workload.
• Expertise within the assigned disciplines and act as subject matter experts.
• Experienced in both plate and gel assays.
• Experience GMP environment.
• Able to work with the gels/plates, exposure with software, Soft Max Pro.
• Must have LIMS experience.

Qualifications: BS in Chemical Engineering with 6 years of Experience

• Knowledge of process engineering training.
• Able to test engineering.
• Knowledge of standards (e.g., testing standards, specification standards).
• Ability to perform quality inspections, quality assurance and quality management technology.
• Ability to perform quality inspections and/or audits.
• Ability to analyze experimental design.
• Knowledge of principles of assessment and reliability.
• Knowledge of human performance in organizations.
• Knowledge of statistical concepts related to quality assurance.
• Ability to analyze equipment and process performance.
• Knowledge of process control strategies and technology.
• Knowledge of principles of applied system reliability.
• Knowledge of Six Sigma concepts.

Qualifications: BS in Biotechnology with 5 years of Experience

• Working knowledge of engineering and supply chain systems (e.g., SQL, TMDB, COBRA, BPCS, PDM).
• Knowledge of inventory management and supply chain planning processes.
• Basic programming skills.
• Strong understanding of documentation processes and quality systems.
• Strong understanding of ISO standards.
• Good analytical and problem-solving skills.
• Ability to exercise good judgment in implementing change orders that affect pricing, costs, and manufacturing processes.
• Ability to effectively communicate with a wide variety of internal and external customers.
• Knowledge of computer applications and the ability to accurately perform tasks in some or all of the following applications: Word, Lotus Notes, Excel and Documentation control systems, FrameMaker, Visio, and HP-UX.

Qualifications: BA in Business Administration with 4 years of Experience

• Proficient with at least one of the following languages (Python, C++).
• Strong team player, having good networking skills, and building partnerships based on mutual trust.
• Exceptional organizational and analytical skills.
• Openness to thinking out of the box and applying new methods.
• Knowledge about quality standards and quality management systems like ISO 9001 or comparable.
• Good in the German and English languages.

Qualifications: BS in Chemistry with 3 years of Experience

• Experience within the Financial Services industry, AML/BSA, KYC, Sanctions, Compliance, Investigative, or Quality Testing/Assurance background.
• Strong research, analytical and comprehension skills, with the ability to analyze large amounts of data.
• Proven ability to identify issues/defects and recommend solutions.
• Demonstrated experience adhering to controls and compliance standards.
• Strong communication skills, including written, verbal, and interpersonal.
• Ability to results-oriented team player.
• Ability to multitask and meet deadlines against a high-volume work schedule.
• Must be detail-oriented, well organized, and a self-starter.
• Must have intermediate-level skills working with the MS Office suite of tools, with an emphasis on Excel and PowerPoint.
• Must have CAMS Certification.

Qualifications: BS in Food Science with 5 years of Experience

• Good initiative and strong team player with good emotional quotient.
• Able to work well under pressure and highly self-motivated.
• Good communication and interpersonal skills.
• Good product knowledge.
• Good project management skills.
• Relevant experience, preferably in the aero-engine part repair environment.

Qualifications: BS in Industrial Engineering with 4 years of Experience

• Strong interpersonal skills and great attention to detail.
• Must be able to handle multiple projects concurrently.
• Knowledge of FDA Regulations, Application of Good Manufacturing Practices.
• Must be a strong team player with good problem-solving and good verbal and written communication skills.
• Experience with a medical device/pharma or other similarly regulated industry.

Qualifications: BS in Biotechnology with 3 years of Experience

• Proficient in computer skills and knowledge of Microsoft Office tools.
• Excellent verbal, written and interpersonal communication skills.
• Must be able to read engineering drawings.
• Knowledge of Quality Regulations.
• Strong attention to detail and the ability to detect small visual defects.
• Must be able to lift up to thirty (30) pounds.
• Able to positive can-do attitude and a strong work ethic.

Qualifications: BS in Pharmaceutical Sciences with 2 years of Experience

• Must have quality work experience.
• General understanding of the aspects of the job.
• Able to work under the close direction of a senior Quality Associate.
• Detail-oriented with problem-solving ability.
• Good organizational and interpersonal skills.
• Basic level of computer literacy.
• Proficient in Word and Excel.
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a team environment.

Qualifications: BA in Operations Management with 1 year of Experience

• Experience working in a lab environment.
• Knowledge of laboratory instrumentation and basic “wet lab” techniques.
• Knowledge of laboratory practices, scientific terminology, and the characterization and preparation of materials used in routine and special procedures.
• Proficient in Microsoft Office applications.
• Must have close attention to detail and quality in results.
• Must be able to establish and meet deadlines to produce independent results, while building a network of resources in the company.
• Must work well with other team members, including design engineers.
• Ability to multitask and manage numerous projects simultaneously.

Qualifications: BS in Biomedical Engineering with 2 years of Experience

• Strong interpersonal skills and great attention to detail.
• Must be a strong team player with good problem-solving and good verbal and written communication skills.
• Must have the ability to manage people, encourage teamwork and drive decisions.
• Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Understanding of verbal and written safety and quality instructions and reading and comprehending written work instructions, including words and drawings.
• Must have basic English written and oral communication skills adequate to communicate with other team members.

Qualifications: BA in Supply Chain Management with 4 years of Experience

• Ability to visually inspect components.
• Ability to communicate, both verbally and in writing, in English, effectively and professionally with employees at all levels of the organization.
• Ability to manage time and ability to prioritize effectively.
• Understand the role of Quality within the organization.
• Ability to move quickly in order to keep the line going.
• Must have basic mathematics.
• Able to legibly handwrite, dependable.

Qualifications: BS in Biology with 1 year of Experience

• Experience in a GMP environment, such as blood banking, pharmaceutical, medical devices, or a hospital.
• Experience in QA, QC, or Quality Auditing.
• Knowledge of federal regulatory requirements pertinent to pharmaceutical, biologic, or medical device manufacturing.
• Good analytical and problem-solving skills.
• Demonstrated effective verbal and written skills.
• Strong skills needed to advance compliance and quality in operations, must deal effectively with management and staff in areas, at BHQ, and outside the organization.
• Must have persuasive skills to achieve compliance with relevant procedures.
• Must display tact, diplomacy and professionalism in difficult situations.
• Must protect the confidentiality of sensitive information in the department.
• Must operate as a team member.

Qualifications: BS in Microbiology with 4 years of Experience

• Fluent English speaking and written skills.
• Experience in quality control, preferably in the e-commerce segment.
• Proficient in MS Office and Google tools.
• Experience in reporting and analysis, able to find patterns/deviations in multi-variable scenarios.
• Must have a quality control mindset, such as logical and critical thinking.
• Excellent verbal, written, interpersonal, analytical and organizational skills.
• Able to manage multiple tasks independently.

Qualifications: BS in Chemical Engineering with 3 years of Experience

• Work experience in thermoforming, printing, or maintenance.
• Must have a computer, language skills.
• Able to be familiar with Windows, Microsoft Outlook, Excel, Word, and Gandainseeker.
• Basic Metrology of Measuring Devices.
• Must have bilingual English/Spanish.
• Must have mathematical skills.
• Basic algebra and geometry.

Qualifications: BS in Pharmaceutical Sciences with 2 years of Experience

• Proficient in Dutch (native Dutch) and English.
• Able to be oriented.
• Good listening skills.
• Willingness to raise issues and recommend solutions.
• Must have IT literacy, Microsoft Outlook, Word, and Excel.
• Highly self-motivated with strong interpersonal skills.
• Must have a team player with good social skills when dealing with other departments.
• Professional and intellectual capacity (Werk-en denkniveau).
• Demonstrated pharmaceutical experience, including working within quality systems such as change control, deviations and deviations.
• Experience working in a GDP warehouse  (or GMP environment), in either a quality or operations role.
• Experience in performing and supporting (internal) audits.

Qualifications: BS in Chemical Engineering with 4 years of Experience

• Experience in the quality field.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Must have mathematical skills.
• Ability to calculate figures and amounts such as discounts, interests, commissions, proportions, percentages, area, circumference, and volume.
• Ability to apply concepts of basic algebra and geometry.

Qualifications: BS in Quality Assurance with 3 years of Experience

• Demonstrated experience in document management in the pharmaceutical/biotechnology/medical device industry.
• Experience with a 21 CFR part 11 and/or ISO 13485 compliant document management system.
• Experience in maintaining Document Control systems and programs.
• Experience with electronic Document Management System Administration.
• Experience with MasterControl.
• Previous experience with regulatory inspections.
• Experience in working with startups.
• Good communication skills and product orientation.

Qualifications: BS in Biomedical Engineering with 4 years of Experience

• Able to pay attention to detail.
• Able to repair, rework and sort good and bad items.
• Able to handle material, including some stacking, packing, or palletizing.
• Able to pay attention to detail, while following all directives, procedures and policies.
• Able to walk, stand, bend, reach, and squat for long periods.
• Experience in a Quality Control or Manufacturing environment.
• Must be able to facilitate and communicate well with production, supervisors, and co-workers.
• Strong computer, problem-solving, and analytical skills.
• Excellent verbal and written communication skills.

Qualifications: BA in Supply Chain Management with 2 years of Experience

• Experience in Manufacturing, QA, QC, R&D in the pharmaceutical or biologics industry.
• Must be familiar with the use of electronic document management and laboratory information management.
• Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.
• Knowledge of GMP and regulatory requirements as related to the drug development process.
• Experience in biologics and or Quality Assurance.
• Able to team player with strong interpersonal, organizational, documentation and communication skills.
• Must have mental agility to handle a broad scope of different types of quality assurance work (e.g., reviewing documentation, focus, communication 1:1 and with larger groups).

Qualifications: BS in Medical Laboratory Science with 3 years of Experience

• Previous manufacturing experience.
• Must have quality experience.
• Must be comfortable working in a fast-paced environment.
• Must have a steady work history.
• Must be detail-oriented.
• Able to work in a typical office environment.
• Able to spend a significant amount of time in operational areas.
• Able to see with eyesight sufficient to make judgments on the identification and visual quality of the product.
• Must be able to spend a lengthy amount of time at the computer creating/searching for information.

Qualifications: BS in Pharmaceutical Sciences with 2 years of Experience