QC Chemist

Role: GMP Quality Control Chemist supporting biologic drug substance and product testing, focusing on potency and impurity assays like ELISA. Responsibilities: perform routine and stability testing, support method qualification and tech transfer, analyze data, support investigations for CAPA, Change Control, Deviations, generate reports, and ensure compliance with GMP and data integrity standards. Work within LabWare LIMS for data trending and documentation, and review batch documentation for product disposition. Requirements: BS in Chemistry or related science, 4+ years GMP chemistry experience, familiarity with GMP regulations, USP/Ph. Eur./FDA/ISO standards; experience with large molecules preferred. High-Value: biologics, GMP Quality Control, potency/impurity assays, stability testing, GMP compliance, LIMS proficiency. WorkSetup: flexible, with potential on-call support.