Senior Quality Assurance Specialist
Vericel Corporation
6 hours ago
On-site
Burlington, MA
Operations
Position Summary
Responsible for QA validation activities for equipment, facilities, and utilities, ensuring systems remain in a validated state and compliant with cGMP requirements. Supports validation lifecycle activities and provides supplemental support to QA Operations including batch record review and product disposition.
Responsibilities
- Perform and support validation lifecycle activities, including authoring/reviewing/approving URS, DQ, FAT, SAT, and IQ/OQ/PQ protocols and reports.
- Support qualification and requalification of equipment, facilities, and utilities (cleanrooms, HVAC, water systems (WFI, RO/DI), compressed gases).
- Provide QA oversight of validation activities and review validation discrepancies to ensure appropriate resolution.
- Support maintenance of validated systems through periodic review and change assessment.
- Review and approve deviations, CAPAs, and change controls, focusing on impact to validated systems and product quality.
- Participate in audits; represent QA as a subject matter expert for validation-related activities.
- Review and approve labeling components (master text and final label proofs) for accuracy and compliance.
- Maintain documentation alignment with manufacturing and labeling requirements.
- Support day-to-day QA operations, including batch record review and product disposition (as needed).
- Identify and escalate compliance issues and support continuous improvement initiatives.
- Participate in risk assessments, investigations, and cross-functional projects.
- Other duties as assigned.
Basic Qualifications
- Bachelor’s degree with 8+ years of industry-relevant experience, or Master’s degree with 6+ years of industry-relevant experience.
- Strong interpersonal skills and ability to work in a team environment.
- Strong written and verbal communication.
- Strong organization and time management.
- Proficient in MS Office.
- Working knowledge of cGMP regulations.
Preferred Qualifications
- Experience overseeing projects.
- Knowledge of electronic batch records, ERP systems, and Quality Management Systems (TrackWise and Veeva).
- Ability to interpret Quality standards for implementation and review.
Working Conditions
- Ability to lift and transport up to 30 lbs.
- Ability to support rotating holiday coverage.
- Ability to work Sunday–Thursday.
- Ability to gown into ISO 7 clean room areas and CNC areas.
Responsible for QA validation activities for equipment, facilities, and utilities, ensuring systems remain in a validated state and compliant with cGMP requirements. Supports validation lifecycle activities and provides supplemental support to QA Operations including batch record review and product disposition.
Responsibilities
- Perform and support validation lifecycle activities, including authoring/reviewing/approving URS, DQ, FAT, SAT, and IQ/OQ/PQ protocols and reports.
- Support qualification and requalification of equipment, facilities, and utilities (cleanrooms, HVAC, water systems (WFI, RO/DI), compressed gases).
- Provide QA oversight of validation activities and review validation discrepancies to ensure appropriate resolution.
- Support maintenance of validated systems through periodic review and change assessment.
- Review and approve deviations, CAPAs, and change controls, focusing on impact to validated systems and product quality.
- Participate in audits; represent QA as a subject matter expert for validation-related activities.
- Review and approve labeling components (master text and final label proofs) for accuracy and compliance.
- Maintain documentation alignment with manufacturing and labeling requirements.
- Support day-to-day QA operations, including batch record review and product disposition (as needed).
- Identify and escalate compliance issues and support continuous improvement initiatives.
- Participate in risk assessments, investigations, and cross-functional projects.
- Other duties as assigned.
Basic Qualifications
- Bachelor’s degree with 8+ years of industry-relevant experience, or Master’s degree with 6+ years of industry-relevant experience.
- Strong interpersonal skills and ability to work in a team environment.
- Strong written and verbal communication.
- Strong organization and time management.
- Proficient in MS Office.
- Working knowledge of cGMP regulations.
Preferred Qualifications
- Experience overseeing projects.
- Knowledge of electronic batch records, ERP systems, and Quality Management Systems (TrackWise and Veeva).
- Ability to interpret Quality standards for implementation and review.
Working Conditions
- Ability to lift and transport up to 30 lbs.
- Ability to support rotating holiday coverage.
- Ability to work Sunday–Thursday.
- Ability to gown into ISO 7 clean room areas and CNC areas.