The Quality Assurance Manager ensures that all products meet legal standards and company quality requirements. This role involves developing quality control processes, managing a team of quality assurance specialists, and conducting regular product audits. The position is crucial for maintaining high customer satisfaction and continual improvement of production processes.
Tips for Quality Assurance Manager Skills and Responsibilities on a Resume
1. Quality Assurance Manager Resume Format
Job Summary:
- Leads and implement all department program governance and program management lifecycle processes
- Leads and implement site level quality improvement initiatives
- Leads a Quality Management & Performance Improvement group by communication with
- Developing staff members, and building consensus for programs and goals that support a the business,
- Plans, develops, and articulates a short/mid/long-term strategic vision for areas of responsibility
- Collaborates and coordinates with the leadership regarding all quality improvement activities
- Identifies, develops, and evaluates quality improvement initiatives
- Ensures that all relevant quality improvement initiatives take place in a timely manner
- Selects, develops, manages, and evaluates direct reports
- Ensures performance appraisals are completed in a timely fashion
Skills on Resume:
- Program Leadership (Hard Skills)
- Quality Improvement (Hard Skills)
- Team Management (Soft Skills)
- Strategic Planning (Hard Skills)
- Collaboration (Soft Skills)
- Initiative Development (Hard Skills)
- Timely Execution (Hard Skills)
- Performance Evaluation (Hard Skills)
2. Quality Assurance Manager Resume Model
Job Summary:
- Create and execute accurate, timely ad hoc reporting as requested by site management.
- Create customized tools and applications to handle the specific reporting needs of the business.
- Actively monitor data trends and communicate issues, opportunities, and outcomes to senior leadership.
- Develop a quality management system framework for the site and work collaboratively with functional leadership.
- Responsible for ensuring that department understands and complies with process and quality standards and requirements as documented.
- Perform data analytics and support performance management for process improvements.
- Ensures the quality of processes performed within the GBS through quality auditing, monitoring & analysis.
- Build a performance-driven culture across the entire organization.
- Undertake people management responsibilities
- Selects, develops, and evaluates personnel ensuring efficient operation of the function.
Skills on Resume:
- Ad Hoc Reporting (Hard Skills)
- Tool Development (Hard Skills)
- Data Monitoring (Hard Skills)
- Quality System Development (Hard Skills)
- Process Compliance (Hard Skills)
- Performance Analytics (Hard Skills)
- Quality Assurance (Hard Skills)
- Leadership and Team Management (Soft Skills)
3. Quality Assurance Manager Resume PDF Editor
Job Summary:
- Manages supplier food safety through 2nd and 3rd party audit programs
- Ensuring supplier compliance to corrective actions, investigating supplier food safety issues
- Managing a recall program with regular mock recalls for all suppliers.
- Manages supplier compliance to quality standards by conducting product evaluations
- Evaluating supplier issues, production data, and developing mitigation plans.
- Manages written product specifications for all products and ingredients
- Working with suppliers to ensure specification parameters are achievable and meet quality standards.
- Manages ingredients, allergens and nutritional information
- Providing up-to-date and accurate data and ensures products are in compliance with allowed ingredients.
- Manages product quality issues through documentation of issues
Skills on Resume:
- Food Safety Auditing (Hard Skills)
- Corrective Action Oversight (Hard Skills)
- Recall Program Administration (Hard Skills)
- Product Evaluation (Hard Skills)
- Issue Resolution (Hard Skills)
- Specification Management (Hard Skills)
- Ingredient Compliance Management (Hard Skills)
- Quality Issue Documentation (Hard Skills)
4. Quality Assurance Manager Resume Template
Job Summary:
- Design, implement, and improve company quality standards
- Review and improve processes in order to ensure that align with current trends and frameworks
- Create reports and update on progress toward KPI's
- Monitor all operations that affect quality throughout the company
- Appraise customers’ requirements and contribute to customer satisfaction
- Perform and review internal auditing for assurance of compliance
- Market research and on-site audits of suppliers and contribute to tender processes
- Audit of plant processes to ensure both internal and external regulations and standards are being adhered to
- Maintain quality auditing and manufacturing documentation
- Act as backup inspection host or back-room support for any GMP-related inspections.
Skills on Resume:
- Quality Standards Implementation (Hard Skills)
- Process Improvement (Hard Skills)
- KPI Reporting (Soft Skills)
- Quality Monitoring (Hard Skills)
- Customer Satisfaction Analysis (Soft Skills)
- Internal Auditing (Hard Skills)
- Supplier Evaluation (Hard Skills)
- Regulatory Compliance Assurance (Hard Skills)
5. Quality Assurance Manager Resume Sample
Job Summary:
- Manage Supplier Quality via conducting supplier surveys and on-site audits
- Assess supplier’s quality and manufacturing capabilities. Drive supplier actions to verify part and process quality.
- Partner with R&D to ensure systems and processes are developed and implemented on new products.
- Perform critical review of Engineering Change Orders related to Quality System requirements.
- Introduction of new quality system technologies, streamlining processes, and improving methods & controls.
- Lead Cost Of Quality through effective communication, training and continuous process improvement with engineering and manufacturing teams.
- Drive conclusions to corrective action investigations, identifying and validating root cause and develop capital projects budgets.
- Develop and analyze quality-reporting measures and reports to management on quality issues, supplier performance, non-conformances, corrective actions, trends and losses, etc.
- Selection, configuration and maintenance of tools
- Directly managing individual SDETs and Test Engineers (both onsite and offshore)
- Defining KPIs and providing reports to management and participating in automated and manual testing efforts
Skills on Resume:
- Supplier Quality Management (Hard Skills)
- R&D Collaboration (Soft Skills)
- Quality System Review (Hard Skills)
- Quality Innovation (Soft Skills)
- Cost Quality Leadership (Soft Skills)
- Corrective Action Solutions (Hard Skills)
- Quality Reporting (Hard Skills)
- Team Management (Soft Skills)
6. Quality Assurance Manager Resume PDF Maker
Job Summary:
- Understanding customer expectations and needs regarding product and developing quality control processes
- Understanding product specifications and translating to quality instructions, alerts, audit/inspection plans, etc.
- Supporting the manufacturing and engineering efforts to release product to production to expected quality levels
- Supervising team and monitoring production performance, team with Production management, sales, and technical teams to ensure compliance with quality standards
- Support validation of raw materials that are used in production and monitoring and evaluating internal production processes
- Evaluating final output of products to verify conformance and design and manage an effective corrective action system
- Engaging with customers and gathering product feedback and producing statistical reports on quality standards
- Reporting to management on quality standard issues and overseeing effectiveness and compliance with quality systems
- Supporting the Team Swords Quality Assurance approach across all plant operations.
- Creating and ensuring value-streams comply with QMS requirements and production targets.
- Conducting reviews of SOA’s and ROA’s, creating templates and internal processes
Skills on Resume:
- Quality Process Development (Hard Skills)
- Product Specification Translation (Hard Skills)
- Manufacturing Support (Hard Skills)
- Team Supervision (Soft Skills)
- Raw Material Validation (Hard Skills)
- Output Evaluation (Hard Skills)
- Customer Engagement (Soft Skills)
- Quality Reporting (Soft Skills)
7. Quality Assurance Manager Resume Download
Job Summary:
- Use and maintain equipment (calibration, repair and record-keeping)
- Perform dimensional and mechanical inspection of samples
- Perform metallographic presentation of samples for inspection, Rocap, tipshear test, Pre installation verification text, and analysis
- Set up inspection reports in software and coordinate witness testing with customers
- Identify and control non-conforming products, ensuring that all non-conforming qualities are documented
- Involve supplier to assist in resolving issues and metallurgical problem solving of defective product
- Complete inspections, and other customer specific inspections as directed by management
- Collaborating closely with Engineering and Devops teams to ensure that quality standards are maintained throughout the SDLC and that QA processes are iteratively improved
- Supporting QMS and Regulatory Compliance in identifying and responding to Quality problems in the production of Commercial IVDD instrumentation
- Providing leadership in New Product and Process Introductions in areas such as initial manufacturing Validation and Product/ Process Stabilization.
- Managing workflow for Paraplanning Dept and allocation of SOA’s and ROA’s
Skills on Resume:
- Equipment Maintenance (Hard Skills)
- Inspection Techniques (Hard Skills)
- Sample Analysis (Hard Skills)
- Report Coordination (Soft Skills)
- Non-Conforming Product Management (Soft Skills)
- Supplier Engagement (Soft Skills)
- Inspection Coordination (Soft Skills)
- Quality Assurance Leadership (Soft Skills)
8. Quality Assurance Manager Resume Example
Job Summary:
- Implement an efficient QMS and a continuous improvement culture within the company.
- Ensure that required QMS processes are documented, established and maintained.
- Analyze deviations and follow-up with Corrective Actions/Preventative Actions (CAPA).
- Supervise batch records in order to release Texere Machined Bone Grafts batches.
- Support, train and advice teams on QA activities or issues.
- Participate in internal/external audits, inspections and provide post-inspection follow-up.
- Select suppliers and subcontractors in accordance with the COO and HBM Manager.
- Write and update SOP, work instructions, and policies.
- Report to the management on the QMS’ effectiveness and on the company’s needs for improvement.
- Oversee positive infectious disease marker documentation, communication, and reporting.
Skills on Resume:
- QMS Implementation (Hard Skills)
- Documentation Management (Hard Skills)
- Deviation Analysis (Hard Skills)
- Batch Record Supervision (Hard Skills)
- QA Training (Soft Skills)
- Audit Management (Soft Skills)
- Supplier Selection (Soft Skills)
- SOP Development (Hard Skills)
9. Quality Assurance Manager Resume Online Editor
Job Summary:
- Maintain all SQF records and documents HACCP, SOPs, GMPs regulatory compliance, sanitation, hold and release
- Plant testing utilizing a high level of understanding of testing requirements regarding product quality assurance
- Manage records and maintenance of technical procedures for laboratory and manage external audits
- Work with plant personnel to ensure all have up-to-date training
- Ensure compliance with GMP and Food Safety requirements for all personnel
- Provides timely feedback to plant leadership team regarding food safety and quality issues.
- Responsible for quality budget, responsible for quality and additional personnel.
- Validation to ensure compliance with internal standards and relevant regulatory requirements.
- Distribution of audit reports and audit CAPAs and maintain audit program tracker and audit files
- Support inspection readiness activities, such as inspection coordination and logistics
Skills on Resume:
- SQF Records Management (Hard Skills)
- Product Quality Testing (Hard Skills)
- Technical Procedure Maintenance (Hard Skills)
- Training Coordination (Soft Skills)
- Compliance Oversight (Hard Skills)
- Issue Reporting (Soft Skills)
- Budget Management (Hard Skills)
- Validation and Compliance (Hard Skills)
10. Quality Assurance Manager Resume PDF Download
Job Summary:
- Manage a team of QA Engineers to ensure the high quality product delivery
- Define manual test strategy, tools and process for quality assurance of Amazon India Retail systems and software
- Lead aggressive organizational goals for test automation and CI/CD
- Define, rollout and enforce best practice processes in the areas of functional, system and regression testing
- Develop test strategies, test plans, and test schedules for new projects and software releases
- Oversee and report on the development, execution and results of test plans
- Participate in project planning and estimates
- Recruit, interview and hire new QA engineers
- Perform internal and external quality audits and compile detailed reports of findings
- Build a strong team through coaching, mentoring, specific training and performance evaluations
Skills on Resume:
- Team Leadership (Soft Skills)
- Test Strategy Development (Hard Skills)
- Automation Management (Hard Skills)
- Process Implementation (Hard Skills)
- Test Planning (Hard Skills)
- Reporting and Analysis (Soft Skills)
- Project Collaboration (Soft Skills)
- Talent Management (Soft Skills)
11. Quality Assurance Manager Resume Guide
Job Summary:
- Facilitate audits and develop and implement the strategy to improve compliance maturity and culture
- Assist in the design and development of governance requirements for assurance activities related to safety
- Identify, analyze and interpret trends, patterns and effectiveness of risk controls
- Ensure that post event management and correspondence is completed and closed out
- Set annual safety related KPIs in accordance with required
- Locate and define new process improvement opportunities
- Ensure that audit and cyclic reports are produced and forward in accordance with required timelines
- Prepare and ensure cyclic presentations are completed in accordance with require timelines
- Ensure that all meeting administration is completed and submitted in accordance with required timelines.
- Design of safety system templates and management of the event management database
Skills on Resume:
- Audit Facilitation (Hard Skills)
- Governance Requirements Design (Hard Skills)
- Risk Trend Analysis (Hard Skills)
- Post-Event Management (Hard Skills)
- Safety KPI Setting (Hard Skills)
- Process Improvement (Soft Skills)
- Report Production (Soft Skills)
- Meeting Administration (Soft Skills)
12. Quality Assurance Manager Resume Format and Download
Job Summary:
- Provide advice on developing and implementing the Laboratory Information Management Systems at new locations and in line with the general and local requirements.
- Coordinating with Cargill’s global teams to ensure compliance with company processes and systems
- Provide input into the training on all system modules, for (new) local key users and for (new) end users on specific implementations and on continuous improvements.
- Drive Food Safety full quality data processing through the tools system integration cross location, and the governance in accordance with the local laws and agreements with customers.
- Lead and provide input on specific Quality Control related projects for laboratories within the organization.
- Independently solve moderately complex issues with minimal supervision, while escalating more complex issues to appropriate staff.
- Partner with multiple cross-functional groups, including external contract services providers, to drive process/product related improvements
- Collaborate with external test labs to ensure the design and execution of test methods is consistent with company policies/procedures and regulatory filings.
- Promote a culture that supports continuous improvement through active communication and functional area participation.
- Facilitate GMP training in functional areas and develop appropriate training for personnel involved in the execution of commercial drug product management.
Skills on Resume:
- LIMS Implementation (Hard Skills)
- Global Compliance Coordination (Hard Skills)
- System Training (Soft Skills)
- Food Safety Governance (Hard Skills)
- QC Project Leadership (Soft Skills)
- Problem Solving (Soft Skills)
- Cross-Functional Collaboration (Soft Skills)
- External Lab Coordination (Hard Skills)
13. Quality Assurance Manager Resume Model and Sample
Job Summary:
- Assure that testing activities including, process validation, commercial product release and commercial stability are performed according to regulatory commitments and defined protocols.
- Review and perform quality control checks of CMC documents in support of regulatory filings and finished product release.
- Perform QA oversight, reviews and audit of process documentation associated with product manufacturing, packaging, and testing to assure timely availability of materials
- Work with external contract service providers to identify process-impa,cting deviations, and investigations
- Ensure prompt documentation and communication to Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
- Review investigations and deviations that may impact product quality
- Make fact based recommendations regarding material dispositions.
- Aid in identifying potential corrective actions and track to ensure completion.
- Investigate and address identified compliance and quality issues
- Develop solutions to correct known and potential compliance and quality concerns.
Skills on Resume:
- Regulatory Compliance Assurance (Hard Skills)
- CMC Document Review (Hard Skills)
- Process Oversight (Hard Skills)
- Vendor Collaboration (Soft Skills)
- Issue Management (Soft Skills)
- Investigation Review (Hard Skills)
- Disposition Recommendations (Soft Skills)
- Corrective Action Tracking (Soft Skills)
14. Quality Assurance Manager Resume Template and Example
Job Summary:
- Develop, revise and coordinate changes to Quality System Procedures and Instructions.
- Lead quality improvement teams and work directly with other departments to review, map processes and improve quality system.
- Work closely with other Quality Managers, and document control.
- Plans, develops and implements Quality/Business System and Environmental management audit plans and schedules.
- Plans and coordinates process audits, which assure the effectiveness
- Interactions of departments such as quality, operations, manufacturing, engineering, planning, sales, or maintenance
- Assure compliance with industry and customer requirements.
- Supervises internal quality systems auditor, and monitor auditor performance.
- Conduct internal auditor training of cross-functional personnel to assure auditors understand internal requirements
- Clarify issues concerning the quality or environmental management system (prior to and during internal audits).
Skills on Resume:
- Procedure Coordination (Hard Skills)
- Improvement Team Leadership (Soft Skills)
- Quality Manager Collaboration (Soft Skills)
- Audit Planning (Hard Skills)
- Process Audit Coordination (Hard Skills)
- Interdepartmental Interaction (Soft Skills)
- Compliance Assurance (Hard Skills)
- Auditor Supervision (Soft Skills)
15. Quality Assurance Manager Resume Sample and PDF Download
Job Summary:
- Develop, apply and maintain quality requirements and standards for auditing process.
- Serve as the primary Quality assurance resource to department supervisor(s) for problem identification, resolution, related to corrective and preventive action system.
- Key focal point for Quality Systems and Process certifications.
- Work closely with ISO 9000:2000/AS 9100 Registrar and coordinate and maintain schedule.
- Maintains and analyzes internal audit results (quality records) to identify opportunities for improvement.
- Develop and maintain effective corrective action and preventive action tracking system, which assures adequate & timely follow-up and closure
- Work company-wide with managers to assure adequate response to corrective and preventive action requests.
- Reports on the status of audits at CPAT and SPR meeting and promote organization in quality associations.
- Escalates to higher management on a continuous basis delinquent and outstanding CARs and RPAs.
- Collaborate with other QA colleagues to ensure GMP training and Inspection Awareness/Readiness training are performed
Skills on Resume:
- Quality Requirement Management (Hard Skills)
- Problem Resolution Support (Soft Skills)
- Certification Coordination (Hard Skills)
- ISO Compliance Management (Hard Skills)
- Internal Audit Analysis (Hard Skills)
- CAPA Tracking System Oversight (Hard Skills)
- Management Collaboration (Soft Skills)
- Reporting (Soft Skills)
16. Quality Assurance Manager Resume PDF Template
Job Summary:
- Establishing procedures for maintaining high standards of quality, reliability and safety.
- Determining and enforcing, through functional teams, quality and safety requirements in accordance with company needs and customer specifications.
- Organizing and promoting plant wide quality improvement efforts and an annual quality improvement plan.
- Evaluating and developing improved techniques for the control of quality and reliability.
- Leading and directing all plant certifications including ISO and SQF.
- Leading internal and external audits and training.
- Serving the customer by being the plant's primary contact for customer complaints and resolutions.
- Ensuring compliance with all facility required GMP's.
- Parterning with other facilities to share and implement quality best practices.
- Leading and developing a team of quality technicians, documentation control specialists and engineers.
Skills on Resume:
- Quality Procedure Establishment (Hard Skills)
- Requirement Enforcement (Hard Skills)
- Quality Improvement Leadership (Soft Skills)
- Control Techniques Development (Hard Skills)
- Certification Management (Hard Skills)
- Audit Leadership (Hard Skills)
- Customer Relations (Soft Skills)
- GMP Compliance Assurance (Hard Skills)
17. Quality Assurance Manager Resume Example and Online Editor
Job Summary:
- Development, improve and control of the Quality Management System, QMS
- Ensuring compliance throughout the organisation (and maintaining accreditations should they become applicable)
- Directly line manage, recruit, motivate, and train the quality team, oversee daily and weekly workflow
- Promote safety and quality awareness in the wider organization
- Train, motivate, coach and correct employees to ensure standards and processes are met
- Ensure compliance with all legislative and regulatory needs of the business relating to standards certification and compliance, maintain a register for the same
- Advise the Senior Leadership Team, SLT, on legislative and regulatory updates and implications
- Work closely with other departments to ensure the appropriate processes and procedures are in place, including test
- Control procedures for product conformance, ensure that those procedures are adhered to
- Management of all quality control, case (complaint) management and trend analyses, root cause analyses
Skills on Resume:
- QMS Management (Hard Skills)
- Compliance Assurance (Hard Skills)
- Team Leadership (Soft Skills)
- Safety and Quality Promotion (Soft Skills)
- Employee Training (Soft Skills)
- Regulatory Compliance (Hard Skills)
- Advisory Support (Soft Skills)
- Cross-Department Collaboration (Soft Skills)
18. Quality Assurance Manager Resume Model and PDF Maker
Job Summary:
- Execute, improve, and implement methods to evaluate the moderation processes and improve to maintain an update and accurate process.
- Ensure that the quality samples are completed within the established times to have detailed information and share it with the interested areas.
- Gather information from quality samples, analyze it and prepare relevant reports to share trends and ensure continuous improvement.
- Supervise that the action plans created to improve trends are executed and that results are effective.
- Keep the team of analysts updated in terms of processes, tools, deliverables, and delivery times.
- Audit through different processes that team of analysts has standardized concepts
- Guarantee that the delivery of service to the client complies with its requirements.
- Ensure First Article Inspections (FAI, demo and final) are effective with the Product Management Department
- Maintenance of an effective internal audit schedule and prepare for and facilitate external audits
- Liaise with all internal and external stakeholders to actively resolve problems
Skills on Resume:
- Quality Management (Hard Skills)
- Timely Reporting (Hard Skills)
- Data Analysis (Hard Skills)
- Action Plan Supervision (Hard Skills)
- Team Communication (Soft Skills)
- Process Auditing (Hard Skills)
- Client Service Compliance (Soft Skills)
- Inspection Coordination (Hard Skills)
19. Quality Assurance Manager Resume Example and PDF Editor
Job Summary:
- Incoming Inspection, Supplier & Material Quality, Production Processes Quality, Quality Engineers Projects, Customer Complaints Process, Compliance for ISO 9001, 14001, MC CQM and managing the personnel of these areas
- Leads all quality improvement activities, identifies, develops, and evaluates quality improvement initiatives
- Implement and maintain the application and discipline of IDEMIA’s 7 Quality Basics
- Decrease customer complaints and improve customer satisfaction through compliance and improvement of the quality standards
- Reduce costs caused by quality related wastage
- Improve the plant's quality platform for better communication of key performance indicators, customer satisfaction, and all quality related information
- Manage response to clients of quality claims presented, including supporting investigation and causation analysis
- Defining corrective actions and verifying effectiveness
- Build and maintain strong working relationships with key department stakeholders across teams, functions, and locations
- Enhance planning, leverage reporting opportunities, and improve processes
Skills on Resume:
- Quality Control (Hard Skills)
- Continuous Improvement (Hard Skills)
- Quality Standards Adherence (Hard Skills)
- Customer Satisfaction Enhancement (Hard Skills)
- Cost Reduction Strategies (Hard Skills)
- Communication Skills (Soft Skills)
- Claims Resolution (Hard Skills)
- Stakeholder Management (Soft Skills)
20. Quality Assurance Manager Resume Template and Format
Job Summary:
- Facilitates identification, prioritization, and initiation of projects, metrics/measures for the QA and functional process areas, continuous and ongoing process improvements.
- Develops appropriate reporting and data analytics to track progress and identify trends
- Identify best practices and skill growth opportunities in functional areas to ensure effective ongoing training of staff
- Work closely with staff to understand each individual needs, level of performance and assist in achieving individual excellence within roles
- Reviews and resolves process and quality control problems/concerns
- Periodically inspects completed quality control checklists, forms, and other documents
- Randomly inspects and verifies quality control checks for conformance to prescribed standards
- Schedules and performs quality audits and reports findings to the Senior Quality Manager
- Develops corrective action plans and ensures timely resolution of findings
- Prepares reports and other documentation required by regulatory agencies and to support the quality function.
Skills on Resume:
- Project Facilitation (Hard Skills)
- Data Analytics (Hard Skills)
- Best Practices Identification (Hard Skills)
- Staff Training (Hard Skills)
- Problem Resolution (Hard Skills)
- Quality Control (Hard Skills)
- Audit Scheduling (Hard Skills)
- Regulatory Reporting (Hard Skills)
21. Quality Assurance Manager Resume Sample and Format
Job Summary:
- Develop, implement and manage quality control systems designed
- Ensure continuous goods quality applications (consistent with established standards of SOPs, customer specifications and regulations).
- Ensure that procedures and policies are appropriate and followed and supervise a team of quality control nationwide.
- Review and approve/reject any document that gives work instructions
- Set requirements such as procedures, protocols, test methods, and specifications-including changes to these documents.
- Ensure the training program for all personnel involved in distribution activities
- Supervise Quality staffs engaged in inspection and testing activities to ensure high productivity and high technical integrity.
- Provide supervisory and technical skills to manage the redressing control team in all warehouses.
- Train, motivate and support the redressing team members to achieve the goal is the quality redressing activities are carried out as commitment.
- Manage label checking of new shipment, returned goods approval, deviation cases related to quality of products, and also contact with clients for quality products issues.
Skills on Resume:
- Quality Control System Development (Hard Skills)
- Compliance Enforcement (Hard Skills)
- Team Supervision (Soft Skills)
- Document Approval Oversight (Hard Skills)
- Procedure Setting (Hard Skills)
- Training Program Management (Hard Skills)
- Inspection Supervision (Hard Skills)
- Redressing Team Leadership (Soft Skills)
22. Quality Assurance Manager Resume Format
Job Summary:
- Collaborates with Senior Quality Leadership to develop and implement the CRU quality management system (QMS)
- Establishes quality goals and initiatives, risk assessments, and ensures regulatory compliance.
- Works with the Director, Quality to develop the ProSciento CRU audit strategy and implement inspection and audit readiness activities.
- Consults on the development of CRU quality systems to support ProSciento for process improvement and new business opportunities.
- Oversees the CRU Quality Audit program, including development and maintenance of the CRU audit schedule, audit plan development, oversight of auditors and/or consultants, and ensures deliverables meet quality standards.
- Conducting and hosting CRU audits and ensuring compliance with associated processes.
- Oversees client qualification, routine, and ad hoc audits as well as external qualification and ongoing audits of CRU vendors and client partners.
- Assists with the management of the CRU document control process, CAPA and deviations process, training program and initiatives, and oversight of CRU vendors.
- Supports concurrent clinical efforts by consulting on projects, representing CRU quality assurance in interactions with customers.
- Ensures CRU SOPs are updated to reflect technological changes, regulatory trends, and best practices.
Skills on Resume:
- QMS Development (Hard Skills)
- Goal Setting (Hard Skills)
- Audit Strategy Planning (Hard Skills)
- Quality Systems Consultation (Hard Skills)
- Audit Program Oversight (Hard Skills)
- Audit Conduct (Hard Skills)
- Client Audit Management (Hard Skills)
- SOP Maintenance (Hard Skills)