QC Chemistry Analyst

Description: The individual in this position should have a working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with Chemistry analysis. The QC Chemistry Review Analyst is responsible for performing high-quality, timely review of QC laboratory documentation to ensure data integrity, regulatory compliance, and adherence to internal SOPs. The documentation reviewer will assess raw data, analytical results, chromatography data, calculations, instrument printouts, and electronic records for completeness, accuracy, ALCOA principles, and traceability; verify that methods and specifications are correctly applied; confirm proper approvals and contemporaneous documentation; and identify, triage, and help resolve discrepancies or errors through deviation and CAPA processes. The individual will collaborate closely with analysts, to clarify data, drive right-first-time execution, and support batch release and stability program timelines. The individual must b...