Senior QA Validation Specialist

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.

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.

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

Working Conditions:

• Ability to lift and transport up to 30 lbs.
• Must be able to support rotating holiday coverage.
• Must be able to work a Sunday through Thursday shift.
• Must be able to gown into classified manufacturing ISO 7 clean room areas, to conduct inspection of final product.
• Must be able to gown into CNC areas.

Why Vericel?

• 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.

The salary range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $93,000 to 110,000 annually.

The actual salary offered will be determined based on factors such as the candidate's qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.

EEO Statement

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.