Manufacturing Compliance Specialist I

Vericel Corporation • Burlington, MA

5d • Onsite

About The Position

The Manufacturing Compliance Specialist I ensures compliant and reliable cell therapy manufacturing by leading manufacturing compliance activities, including deviation investigations, CAPA implementation, manufacturing documentation, validation support, technology transfer, inspection readiness, and continuous improvement. The role works within approved procedures, partners with the Quality Unit and other site functions, and promptly escalates product, process, safety, and data integrity concerns.

This position is onsite five days a week, Monday through Friday, between Vericel’s Burlington, Massachusetts office and Cambridge office. The role includes rotating on-call weekend coverage or coverage as required, as well as rotating holiday coverage. The successful candidate will support manufacturing in a regulated biopharmaceutical environment and provide guidance to manufacturing personnel on documentation, investigations, and GMP compliance.

Requirements

• BA/BS in a scientific discipline or equivalent experience preferred.
• 3–5 years of experience in a biopharmaceutical manufacturing environment.
• Familiarity with computer systems such as OpCenter, ERP, MES, EBR, and Veeva.
• Familiarity with biopharmaceutical equipment and manufacturing systems.
• Knowledge of current Good Manufacturing Practices and regulatory requirements.
• Excellent written and verbal communication skills.
• Organizational and planning skills, and ability to cooperate with others in a team environment.
• Experience with Microsoft Office.
• Ability to gown and gain entry to manufacturing areas.

Nice To Haves

• Experience in cell therapy, biologics, aseptic processing, or another high-complexity manufacturing environment.
• Lean Six Sigma certification or experience.
• Root Cause Analysis, GEMBA Problem Solving, or equivalent certification or experience.
• Experience with Human Error Prevention Programs (HEPP).
• Basic laboratory skills, including working with mammalian cell culture.
• Experience working in an ISO 7 cleanroom environment.

Responsibilities

• Lead routine and moderately complex manufacturing deviation investigations, determine immediate and contributing causes using approved methods, develop corrective actions, and escalate complex or cross-functional events as appropriate.
• Own assigned deviation, CAPA, and change control records from initiation through closure, ensuring timely investigations, effectiveness checks, and documentation.
• Apply approved root cause and human performance tools.
• Support product, process, equipment, facility, validation, and data impact assessments with Manufacturing and Quality subject matter experts.
• Follow cGMP, Good Documentation Practice, site procedures, and data integrity requirements when creating, reviewing, correcting, or approving records.
• Author and independently revise manufacturing procedures, batch records, forms, and work instructions, assessing impacts to training, validation, and controlled documentation.
• Support periodic document reviews and change implementation, including training impact.
• Use manufacturing and quality systems, including MES (EBR), ERP, advanced planning, electronic document management, and eQMS, in accordance with access, security, and record control requirements.
• Perform routine manufacturing compliance assessments, identify procedural or execution gaps, recommend corrective actions, and partner with functional leaders to implement sustainable improvements.
• Support troubleshooting by collecting process information, reviewing available data, and coordinating subject matter input without making unauthorized process changes.
• Contribute to Lean and continuous improvement activities while preserving validated state, change control requirements, and product quality controls.
• Analyze recurring deviation trends, identify systemic process weaknesses, lead or co-lead continuous improvement initiatives, use manufacturing metrics to prioritize opportunities, and support process robustness improvements.
• Maintain personal training and role qualification in a current state.
• Coordinate assigned inspection readiness activities, prepare manufacturing documentation, respond to auditor requests, and support regulatory inspections as a manufacturing subject matter resource.
• Provide manufacturing personnel guidance on documentation practices, deviation investigations, and GMP compliance.
• Work rotating on-call weekend coverage or as required, and rotating holiday coverage.

Benefits

• Career growth opportunities.
• Bonus, incentive pay, equity, and benefits may be provided in addition to base compensation; specific benefits are not detailed.

What This Job Offers

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