Quality Control Specialist

The Quality Control Specialist will support cGMP routine testing of raw materials, drug substances, and finished products within a manufacturing environment and affiliated contract organizations. This on-site role is responsible for executing and troubleshooting analytical and bioassay methods, leading method transfers and qualification activities, and ensuring compliance with cGMP and regulatory standards. The position serves as a bioassay subject matter expert, collaborating cross-functionally with Manufacturing, Quality Assurance, and Development, while supporting routine testing, special projects, audit readiness, and continuous improvement initiatives. Additional responsibilities include authoring and revising SOPs, protocols, and reports; reviewing, analyzing, and trending data; managing quality records such as investigations, change controls, and CAPAs; training and mentoring analysts; and maintaining a safe laboratory environment. The ideal candidate holds a BA/BS degree in a STEM field with at least five years of hands-on experience in a cGMP laboratory, including expertise in mammalian cell culture, cell-based assays, ELISA, protein analysis, and IVRPE. Experience in method validation and qualification of cell-based or protein assays, along with a strong Right-First-Time execution mindset, is highly preferred. #J-18808-Ljbffr Katalyst CRO