Quality Assurance Associate
Core
Perform QA batch record review, label review, verifications, and document archival to support product pipeline advancement and lot closure.
Role type
Quality Assurance Associate (GMP)
Builds
Manufacturing batch documentation, quality control data, and material release documentation for finished products and raw materials.
Domain
Biotechnology / Cell Therapy / GMP Manufacturing
Required skills
GMP regulated industry experience, batch record review, material release documentation, document archival, QA metrics tracking, on-floor QA support, MS Office proficiency
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; 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; Administrative Tracking of QA metrics; On the Floor QA support
