Quality Control Analyst I

Role: Perform analytical testing for the release of clinical and commercial gene therapy drug products, ensuring quality and compliance. Responsibilities: conduct finished product and stability testing, review data, support investigations and CAPAs, participate in method validation and transfer, maintain documentation, manage laboratory materials, and uphold audit readiness. Requirements: Bachelor's in life sciences; experience with techniques such as cell culture, ELISA, qPCR, Southern and Western blot; proficiency in MS Office; strong scientific writing skills; self-motivated with adaptability. Preferred: environmental monitoring experience. HighValue: gene therapy, biologics, clinical and commercial manufacturing, QC testing, analytical method validation, GxP compliance, audit readiness. Collaboration: support QC management, work with laboratory teams. WorkSetup: not specified; likely on-site given laboratory focus.