QC Analyst II

Job description

Description Position Summary: The QC Analyst II will be responsible for analytical testing and data verification 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, Raw materials and stability programs. · 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, and authoring of documents and reports. - Performs other functions as required or assigned - Complies with all company policies and standards - Perform...