Job Type
Full-time
Description
Purpose The Lead, Quality Assurance (QA) is responsible for supporting clinical and commercial product quality through QA review of product-related records, batch documentation, QC and environmental monitoring data, donor eligibility records, and other quality documentation to support batch disposition and product release. This role also supports QMS processes, including controlled document review and approval, SOP periodic review, training assignments, and training compliance, while supporting change controls, investigations, OOS/OOT events, CAPA activities, audits, regulatory interactions and cross-functional QA guidance to maintain compliance with cGMP, GTP, applicable health authority regulations, and Celularity quality standards.
Role & Responsibilities - Conducts 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.
- Reviews batch-related documentation, makes quality decisions supporting product release, performs batch disposition, and verifies completion of associated quality event activities.
- Issues batch records and labels and conducts QA verification and reconciliation of product packaging and labeling.
- Supports incoming materials inspection and release and resolves documentation errors or discrepancies with appropriate personnel.
- Handles product-related quality events, including change controls, investigations, OOS/OOT events, CAPA coordination, follow-up, action-item tracking, and timely closure.
- Writes, reviews, and approves SOPs and associated documents, including work procedures and forms, and provides input to improve processes and procedures.
- Serves 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.
- Supports administration of QMS processes such as document control, training assignments, periodic SOP reviews, and training compliance to maintain inspection readiness and procedural effectiveness.
- Implements and ensures adherence to applicable Health Authority regulations, cGMP & GTP requirements, and Celularity quality standards.
- Supports self-inspections, external audits, regulatory filings, and interactions with FDA, partners, and inspectors; serves as audit host as needed.
- Provides day-to-day QA guidance to peers and cross-functional partners and serves as QA point of contact for assigned product or operational areas.
- Completes job-related training in electronic database systems, GMP, safety, and Ethics & Compliance requirements.
Requirements
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
***THIS ROLE DOES NOT PROVIDE RELOCATION
***NO AGENCIES PLEASE
