Quality Assurance Associate
Core
Perform QA batch record review, label review, verifications, and document archival to support product disposition and lot closure in a GMP-regulated environment.
Role type
Quality Assurance Associate (Manufacturing/Regulatory)
Builds
Manufacturing batch records, quality control data, and regulatory documentation for cell/gene therapy products.
Domain
Biotechnology / Cell & Gene Therapy / GMP Manufacturing
Required skills
GMP compliance knowledge, batch record review, document archival, material release documentation, QA metrics tracking, on-floor QA support, MS Office proficiency, cell culture knowledge
Preferred skills
Cell or Gene Therapy experience, cell therapy manufacturing process knowledge
Responsibilities
Review routine manufacturing batch documentation and quality control data; Review routine material release documentation; Coordinate and manage timelines for batch record reviews; Work with Doc Control to ensure archival of batch records; Provide quality assurance support across technical operations functions; Handle other duties as requested by supervisor/manager; Track QA metrics; Provide on-the-floor QA support
Seniority
Junior, 1-2 years experience
