Job Summary: 

• Manage the Global document implementation program (1QSYS) locally, ensuring all Global policies and procedures are adopted fully and in a timely manner.
• Create and maintain a Quality dashboard for Systems and Operations.
• Responsible for providing real-time data and updates as to the status of Quality Compliance across the department.
• Provide support for the following activities within the Quality Systems team.
• Responsible for the governance of non-conformance and change control records within TW8.
• Develop and maintain the Head Office training plans.
• Provide Quality onboarding training sessions.
• Responsible for BAXU training system support.
• Responsible for document processing activities, periodic review, and follow-up.
• Responsible for field action mailouts and customer response tracking.
• Responsible for the governance of non-conformance and change control records within TW8.
• Develop and maintain the Head Office training plans.
• Responsible for document processing activities, periodic review follow-up.
• Responsible for field action mailouts and customer response tracking.
• Lead and/or participate in departmental process improvement initiatives.
• Support overall validation activities related to lane qualification.
• Manage the internal Quality SharePoint site.
• Support on PEGA merchandising approvals for the Quality team.

Skills on Resume:

• Document Management (Hard Skills)
• Dashboard Reporting (Hard Skills)
• Compliance Monitoring (Hard Skills)
• Change Governance (Hard Skills)
• Training Development (Hard Skills)
• Onboarding Training (Hard Skills)
• Process Improvement (Soft Skills)
• SharePoint Management (Hard Skills)

Job Summary: 

• Responsible for review of quality-related documentation and approval of events and change control, including assessing the risk and impact to the process and/or product.
• Write professional reports (PQRs), analyze data and identify and assess quality risk in activities and processes according to guidelines and standard operating procedures.
• Initiate document change proposals, prepare/review/approve protocols to justify process changes, approve validation protocols, and assist with training and auditing.
• Lead ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities.
• Write Product Annual Review Reports for multiple products.
• Responsible for overseeing the closure of nonconformance reports pertaining to areas of responsibility.
• Apply problem-solving tools and methods to coordinate and/or lead investigation teams.
• Lead investigations (i.e., CAPA) for process failures within respective areas.
• Responsible for trending and analyzing data, and presenting Quality System indicators to all organizational levels.
• Act as a change agent and drive continuous improvement activities within the QA Formulation and Filling organization and across the facility.
• Proactively participates in processes and serves as a driver for general process/system improvements.
• Perform technical writing of reports.
• Proofread and reconcile data for accuracy.

Skills on Resume:

• Document Review (Hard Skills)
• Data Analysis (Hard Skills)
• Change Control (Hard Skills)
• Report Writing (Hard Skills)
• Investigation Leadership (Hard Skills)
• Problem Solving (Soft Skills)
• System Improvement (Soft Skills)
• Department Leadership (Soft Skills)

Job Summary: 

• Coordinate the testing schedule at the beginning of each shift.
• Communicate with manufacturing what needs to be tested and when it will be ready to test.
• Maintain the testing schedule to ensure that all products are tested.
• Perform applicable testing on inbound raw materials.
• Perform applicable in-process testing and finished product testing.
• Enter test data in the appropriate files on the computer.
• Prints out test data sheets when testing is complete, signs and gives them to the QA Manager for review.
• Communicates test results that are out of range with the QA manager.
• Keep the test sample board and log up to date.
• Ensure that all material in the QA testing areas and the lab is properly identified and labeled.
• Communicate all issues, concerns, and maintenance and supply needs to the supervisor.
• Update appropriate incoming shift personnel on applicable QA related activities.
• Keep the lab and surrounding areas organized and clean.
• Help the QA Supervisor with the documentation maintenance of specifications and R&D projects.
• Be in charge of faxing or emailing copies of the COA to the customer.

Skills on Resume:

• Testing Coordination (Hard Skills)
• Manufacturing Communication (Soft Skills)
• Material Testing (Hard Skills)
• Data Entry (Hard Skills)
• Result Reporting (Hard Skills)
• Sample Management (Hard Skills)
• Documentation Support (Hard Skills)
• Customer Communication (Soft Skills)

Job Summary: 

• Work across functions to support the development and maintenance of incoming sample management.
• Conduct and document material, component, and packaging sampling according to the established sampling plans.
• Support the development of sampling plans across the product lifecycle.
• Conduct sampling according to established procedures.
• Support and participate in testing and Acceptable Quality Level (AQL) checks and document the results using proper documentation practices.
• Ensure that all aspects of the handling and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
• Support the shipment of samples to the appropriate external testing facilities.
• Complete laboratory inventory and ordering supplies.
• Participate and/or lead various Quality Systems processes, including change controls, investigations, and corrective and preventative action (CAPA) plans.
• Proactively identify and work collaboratively to resolve problems, taking risk-based and compliant approaches to solutions.
• Practice and promote a safety and quality mindset and quality excellence approach to all activities.

Skills on Resume:

• Sampling Management (Hard Skills)
• Material Sampling (Hard Skills)
• Sampling Plan Support (Hard Skills)
• AQL Testing (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Sample Shipment (Hard Skills)
• Quality Systems Support (Hard Skills)
• Problem Solving (Soft Skills)

Job Summary: 

• Lead ongoing, daily departmental operations of medical devices and drug products, local and global distribution.
• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
• Assess and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
• Work closely with supervisors, Quality, Operations and other internal groups to accomplish the above and influence necessary actions.
• Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
• Develop plans to correct identified risks, including areas of non-conformance.
• Inform management and implement approved corrective action plans.
• Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements.
• Provide training and coaching to local employees and in relevant areas.
• Assist other Quality areas in the successful performance of these activities.
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills.
• Support process with timely closure of observations/audit items.
• Oversee audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
• Participate in QA/QC multi-site projects in the role of contributor, coordinator, or lead.
• Sustain a clean and safe work area using 6S principles.
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).

Skills on Resume:

• Operations Leadership (Soft Skills)
• Risk Assessment (Hard Skills)
• Process Investigation (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Process Evaluation (Hard Skills)
• Corrective Actions (Hard Skills)
• Regulatory Expertise (Hard Skills)
• Training Coaching (Soft Skills)

Job Summary: 

• Track QC laboratory activities, equipment calibration and maintain stock of test consumables.
• Perform necessary product release testing for all formula products (RTD and powders) and select food products.
• Communicate product deviations and OOS materials to the quality manager and production staff to assist in determining required CAPAs and nonconforming materials disposition.
• Maintain, update, and execute the food safety plans, standard operating procedures, and work instructions for quality-related tasks.
• Lead the food safety team, and conduct periodic review meetings of the food safety plans.
• Conduct pre-op swabs on food contact surfaces to assure cleanliness and absence of allergens prior to production activities.
• Provide package integrity testing support and training to filler operators to manage successful TBA operations.
• Assist the warehouse coordinator in receiving ingredients as per ACI specification with correct documentation (e.g., certificates of analysis or conformance certificates).
• Provide quality-related oversight and feedback to manufacturing staff.
• Serve as a liaise between kosher and halal certifying bodies with respect to ACI Operations and finished products.

Skills on Resume:

• QC Tracking (Hard Skills)
• Product Testing (Hard Skills)
• Deviation Reporting (Hard Skills)
• Food Safety Management (Hard Skills)
• Safety Team Leadership (Soft Skills)
• Pre Op Inspection (Hard Skills)
• Package Testing Support (Hard Skills)
• Ingredient Receiving (Hard Skills)

Job Summary: 

• Maintain quality management system (QMS) documents, including creating, editing, and reviewing process and procedure documents, technical procedures, work instructions, forms, and templates.
• Assist with improving QMS per ISO/IEC 17025 and updating documents to reflect current lab practices.
• Work with engineering staff to update technical procedures and work instructions.
• Research and collaborate on ways to improve all areas of the lab.
• Help implement and communicate quality changes.
• Record action items and follow up on corrective actions.
• Record equipment maintenance and repairs.
• Help maintain training records for employees.
• Assist with asset management and calibration.
• Responsible for quotes for calibration, generating POs, and preparing shipments to vendors.
• Receive and check-in calibrated equipment.
• Update calibration schedule.
• Assist with in-house calibrations.
• Assist the quality manager with internal auditing.
• Review and approve data sheets and test reports.
• Support any additional efforts for lab approval under other governing bodies (DLA, NAVAIR, etc.

Skills on Resume:

• QMS Documentation (Hard Skills)
• ISO Improvement (Hard Skills)
• Procedure Updates (Hard Skills)
• Lab Collaboration (Soft Skills)
• Quality Communication (Soft Skills)
• Corrective Actions (Hard Skills)
• Equipment Maintenance (Hard Skills)
• Training Records (Hard Skills)

Job Summary: 

• Visually inspect and/or test all materials shipped into the facility to determine if the material meets specifications and standards.
• Audit processes to ensure quality standards and defect ranges (panoplies) are being met.
• Document audits and maintain appropriate records.
• Process off-specification material.
• Effectively work and communicate with others in the organization and with customers.
• Inform the supervisor of major and critical defects found during inspections.
• Verify that corrective action is taken to resolve defects.
• Participate in location inventories.

Skills on Resume:

• Material Inspection (Hard Skills)
• Process Auditing (Hard Skills)
• Audit Documentation (Hard Skills)
• Material Disposition (Hard Skills)
• Team Communication (Soft Skills)
• Defect Reporting (Hard Skills)
• Corrective Verification (Hard Skills)
• Inventory Support (Hard Skills)

Job Summary: 

• Monitor production to ensure all documentation is complete.
• Monitor scaling of raw materials, mixing of batter and icing to ensure compliance with formula cards (i.e., correct ingredients, correct lot codes, quantities).
• Audit compliance of specific gravity and temperatures.
• Monitor the baking process to ensure baking specifications are being followed, check the product for doneness, compare to color standards, and check internal temperatures.
• Monitor the cooling process to ensure the product is being adequately cooled without any adverse effects.
• Ensure product specifications, weights, color and other attributes of the finished product.
• Monitor packaging to ensure correct labelling, date coding, and that correct packaging is being followed.
• Accountable for organoleptic tests of finished goods to ensure acceptance to standards, taste, eye appeal, odor, etc.
• Advise the QA Manager regarding questionable product, discarding of bad product, or possible stopping of the production line to correct or prevent product quality issues.
• Monitor production processing and assist operators in making adjustments to processing methods during production to improve product quality and consistency.
• Monitor metal detectors and scales to ensure complete accuracy.
• Assist production employees with label printing.
• Work with production and warehouse to control, maintain, and/or improve the handling, storage and usage of all other materials.
• Provide individual or group training to production employees on Standard Operating Procedures (SOPs), product specifications, SPC, production controls, formulas, visual quality inspection criteria, GMP, and Food Safety procedures.
• Assist in the development of SOPs by working with production operators to understand current operating procedures, identify best methods, and help document new and/or update existing standard operating procedures.
• Assist in developing HACCP plans, SOP's and maintaining food safety programs for BRC/AIB audits.
• Perform GMP inspection.
• Control and retain samples and associated reports.

Skills on Resume:

• Production Documentation (Hard Skills)
• Formula Compliance (Hard Skills)
• Process Auditing (Hard Skills)
• Baking Monitoring (Hard Skills)
• Packaging Verification (Hard Skills)
• Organoleptic Testing (Hard Skills)
• Quality Issue Escalation (Soft Skills)
• SOP Training (Soft Skills)

Job Summary: 

• Lead, contribute and approve quality-related activities such as non-conformance, deviation, OOT, OOS and complaint investigations.
• Ensure adequate root cause analysis as well as identification and implementation of corrective and preventative actions (CAPA).
• Administrate quality systems to include document change management, change control, complaint and event management.
• Maintain quality systems metrics, including trending, and preparation of reports to management in an effort to drive the process of continuous improvement throughout Aquestive.
• Prepare, review and approve Standard Operating Procedures in order to maintain quality systems that are in line with current regulations and industry standards.
• Analyze system and document changes for appropriateness and ensure adequate impact analysis is performed.
• Review and approve system and document changes.
• Review executed manufacturing batch records, analytical data, and associated documentation related to material disposition.
• Provide batch disposition and final release.
• Conduct internal and external issues and approve audit reports and responses.
• Ensure all CAPAs associated with internal and external audits are completed appropriately and in a timely manner.
• Partner with the production team, providing services in preparation for and during manufacturing activities to assure appropriate consistency in GMP systems applied across manufactured products.
• Provide training and implement actions that have an impact internally across other functions as well as externally with companies and organizations involved in GMP manufacturing.
• Provide guidance and support to production quality issues, not limited to making product impact assessments and participating in Go/No Go decisions.
• Drive closure of open items (change control, CAPA) in a timely manner.
• Prepare Annual Product Reviews for management review.
• Contribute to the development, planning and implementation of Aquestive quality strategy and policy.
• Participate in all site compliance efforts as well as onsite regulatory agency inspections, corrective action implementation and agency response.

Skills on Resume:

• Quality Investigation (Hard Skills)
• Root Cause Analysis (Hard Skills)
• Systems Administration (Hard Skills)
• Metrics Trending (Hard Skills)
• SOP Management (Hard Skills)
• Impact Analysis (Hard Skills)
• Batch Disposition (Hard Skills)
• GMP Support (Soft Skills)

Job Summary: 

• Perform frequent line inspections.
• Carry out data collection and recognize errors or deviations.
• Communicate with production personnel and team leaders to resolve basic quality issues.
• Enforce Good Manufacturing Practices and safety policies.
• Provide QA coverage for assigned production lines.
• Demonstrate good work habits with attention to detail.
• Ensure compliance with quality standards, SOP’s and programs are being met.
• Communicate all product deviations to the Quality Supervisor or Quality Lead.
• Participate in Quality Line Audits.
• Assist workers in solving daily work problems.
• Perform ATP swabbing to ensure sanitation requirements are met.
• Assist in the Sample Retain Program.
• Verify label accuracy and application.
• Confirm accurate code formatting.
• Accurately complete production line quality documents.
• Calibrate equipment for quality monitoring.
• Ensure samples are delivered to the laboratory for testing in accordance with sampling plans.
• Provide metrics and reports that are complete and timely.
• Contribute useful problem-solving options and implement successfully.
• Provide improvement options that positively impact the company's objectives.

Skills on Resume:

• Line Inspection (Hard Skills)
• Data Collection (Hard Skills)
• GMP Enforcement (Hard Skills)
• Quality Compliance (Hard Skills)
• Deviation Reporting (Hard Skills)
• Problem Solving (Soft Skills)
• Equipment Calibration (Hard Skills)
• Metrics Reporting (Hard Skills)

Job Summary: 

• Manage the P3 file review system for all YIN programs.
• Create systems to ensure compliance with all COA standards and expectations for file reviews.
• Ensure programs conduct P3 file reviews on a quarterly basis.
• Maintain an organized system to track status.
• Follow up and coordinate with program management.
• Receive tally sheets from all programs/sites and convert tallies into percentages and enter data into spreadsheets.
• Produce and distribute reports (approx. 25 of them) each quarter to program management.
• Distribute reports to the P3 File Review Committee.
• Participate as a member of the P3 File Review Committee.
• Ensure feedback forms are returned, archived, and followed up on.
• Annually review and update the number of files needed for program file reviews based on numbers served from the previous program year and communicate to program management.
• Coordinate with program management to ensure the content of file review checks is reviewed annually and updated.

Skills on Resume:

• File Review Management (Hard Skills)
• Compliance Systems (Hard Skills)
• Quarterly Monitoring (Hard Skills)
• Status Tracking (Hard Skills)
• Data Conversion (Hard Skills)
• Report Production (Hard Skills)
• Committee Participation (Soft Skills)
• Program Coordination (Soft Skills)

Job Summary: 

• Responsible for reviewing customer complaints.
• Conduct CAPAs, follow and update SOPs, and document QC procedures.
• Conduct specification checks and documentation.
• Responsible for liaising with customers.
• Conduct Quality auditing, reviewing documentation.
• Ensure compliance with the requirements of ISO9001 and ISO14001.

Skills on Resume:

• Complaint Review (Hard Skills)
• CAPA Execution (Hard Skills)
• SOP Maintenance (Hard Skills)
• Specification Checks (Hard Skills)
• Customer Liaison (Soft Skills)
• Quality Auditing (Hard Skills)
• ISO Compliance (Hard Skills)
• QC Documentation (Hard Skills)

Job Summary: 

• Work on the production flow in Inspection, Sorting, and Containment, as well as perform Rework.
• Responsible for using inspection, measuring, and testing equipment.
• Perform a full range of varied inspection tasks, including visual and touchpoint inspection.
• Perform administrative duties related to quality project work.
• Read and follow written and verbal work instructions.
• Identify problems and questions and report them to the appropriate supervisor.

Skills on Resume:

• Production Flow Support (Hard Skills)
• Equipment Operation (Hard Skills)
• Inspection Execution (Hard Skills)
• Quality Administration (Hard Skills)
• Work Instruction Compliance (Soft Skills)
• Problem Reporting (Soft Skills)
• Sorting Containment (Hard Skills)
• Rework Handling (Hard Skills)

Job Summary: 

• Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor against cGMPs to assure real-time observation of activities, issue identification/resolution, including proper and timely documentation.
• Provide guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assist in the resolution of issues identified.
• Proactively shared across QA and the business, including the ongoing training of junior team members.
• Identify, classify and report deviations, and typically work on more complex Minor and/or Major deviations.
• Oversee execution of remediation/CAPA activities required to continue production or move a process to the next milestone.
• Work closely with others to determine root cause and potential preventative/corrective actions.
• Ensure support for the timely closure of investigations.
• Provide guidance and control directives regarding remediation activities required to continue production.
• Resolve critical issues within the assigned area and may escalate to the senior management team based on the severity of the issue.
• Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls.
• Provide plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.
• Perform independent technical review of documentation during and post-execution of cGMP activities.
• Sign off/qualify/train junior staff on QA Operation responsibilities.
• Ensure all specifications are met and that applicable requirements are completed and acceptable.
• Ensure all issues/documentation associated with each process in the assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.
• Analyze and report findings to the appropriate departments.
• Work closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of BIFI's Quality Systems.
• Attend as a QA project team member to provide QA guidance and oversight to such improvements.
• Serve as Subject Matter Expert for internal or external matters.
• Participate in inspection readiness activities and are significantly involved in inspections by regulatory agencies.
• Create and establish processes and procedures to ensure compliance and adherence to regulated QA activities for cGMP operations.

Skills on Resume:

• QA Operations (Hard Skills)
• Regulatory Guidance (Hard Skills)
• Team Training (Soft Skills)
• Deviation Management (Hard Skills)
• CAPA Oversight (Hard Skills)
• Root Cause Analysis (Hard Skills)
• Change Control Support (Hard Skills)
• Process Improvement (Soft Skills)