QC Analyst III

Job description

Description Position Summary: The QC Analyst III will be responsible for analytical testing and data verification/review supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories. A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required. Essential Duties & Responsibilities: · Analytical testing to support product in-process, release, and stability programs. · Perform the data verification/Review process as assigned. · Participate in Method Validation activity. · Preparation of the Protocols/Reports as assigned. · Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance. · Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans. · Work with cross-functional teams to advance projects, maintain equipment, a...