Senior Quality Assurance Specialist

Vericel Corporation • Burlington, MA

11h • $93,000 - $110,000 • Onsite

About The Position

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary:

Responsible for QA validation activities for equipment, facilities, and utilities, ensuring systems remain in a validated state and compliant with cGMP requirements. This role supports validation lifecycle activities and provides supplemental support to QA Operations including batch record review and product disposition.

Schedule: This position is in-office Sunday-Thursday in our new Burlington, MA location, but will be required to spend some days in our Cambridge office as we transition to our new facility.

Requirements

• Bachelor’s degree plus a minimum of 8+ years of industry relevant experience or Master's Degree plus a minimum of6years 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 skills.
• Proficient in MS Office.
• Working knowledge of cGMP regulations.

Nice To Haves

• Experience in overseeing projects.
• Knowledge of electronic batch records, ERP systems, and Quality Management Systems (TrackWiseand Veeva).
• Ability to interpret Quality standards for implementation and review.

Responsibilities

• Perform and support validation lifecycle activities including authoring, reviewing, and approving URS, DQ, FAT, SAT, and IQ/OQ/PQ protocols and reports.
• Support qualification and requalification of equipment, facilities, and utilities including cleanrooms, HVAC systems, water systems (WFI, RO/DI), and 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.
• Perform QA review and approval of deviations, CAPAs, and change controls with focus on impact to validated systems and product quality.
• Participate in audits and represent QA as a subject matter expert for validation-related activities.
• Support review and approval of labeling components including master text and final label proofs to ensure accuracy and compliance with product requirements.
• Support maintenance of documentation to ensure 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.

Benefits

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level