Lead, Quality Assurance

Minimum Qualifications (Must have)

• Bachelor’s degree in scientific discipline required.
• Minimum of 5+ years of quality assurance experience in a cGMP-regulated environment.
• Familiarity with cGMP and GTP environments
• Ability to understand, follow, interpret and apply good laboratory practices.
• Knowledge of OOS, OOT, investigation, and CAPA processes.
• Strong organizational and time management skills
• Ability to work well in a team environment
• Dynamic individual with the ability to communicate and engage others
• Independent and self-starting.
• Eager and adaptable
• Excellent verbal and written communication skills as well as strong focus and attention to detail.
• Ability to don personal protective equipment (PPE) during various role responsibilities

Role & Responsibilities

1. 1Conducts QA review of product-related records, biobanking files, transplantation documentation, batch records, QC/environmental monitoring data, donor eligibility records, calibration records, and validation documentation for completeness, accuracy, compliance, and applicable trends.
2. 2Reviews batch-related documentation, makes quality decisions supporting product release, performs batch disposition, and verifies completion of associated quality event activities.
3. 3Issues batch records and labels and conducts QA verification and reconciliation of product packaging and labeling.
4. 4Supports incoming materials inspection and release and resolves documentation errors or discrepancies with appropriate personnel.
5. 5Handles product-related quality events, including change controls, investigations, OOS/OOT events, CAPA coordination, follow-up, action-item tracking, and timely closure.
6. 6Writes, reviews, and approves SOPs and associated documents, including work procedures and forms, and provides input to improve processes and procedures.
7. 7Serves as a QA/QMS approver for controlled documents, including SOPs, work instructions, forms, and related procedural documents, ensuring appropriate review, approval, effectiveness, and alignment with applicable quality system requirements.
8. 8Supports administration of QMS processes such as document control, training assignments, periodic SOP reviews, and training compliance to maintain inspection readiness and procedural effectiveness.
9. 9Implements and ensures adherence to applicable Health Authority regulations, cGMP & GTP requirements, and Celularity quality standards.
10. 10Supports self-inspections, external audits, regulatory filings, and interactions with FDA, partners, and inspectors; serves as audit host as needed.
11. 11Provides day-to-day QA guidance to peers and cross-functional partners and serves as QA point of contact for assigned product or operational areas.
12. 12Completes job-related training in electronic database systems, GMP, safety, and Ethics & Compliance requirements.