QC Compliance Specialist

Role: Quality Systems Investigator supporting deviation and CAPA management within a biopharma QC environment. Responsibilities: lead deviation investigations to determine root causes, implement CAPAs, utilize investigation tools, track investigation statuses, and serve as QC liaison; participate in lean initiatives to improve lab efficiency; provide technical support for QC functions; manage work orders and review investigation/trend data; develop and maintain controlled documentation. Requirements: Bachelor's degree with 2+ years' experience; knowledge of cGMP, FDA requirements, laboratory systems (SAP, LIMS, Trackwise), and investigation writing; strong organizational, communication, and technical writing skills. HighValue: QC investigation and deviation management, CAPA ownership, controlled document control, investigation systems, trend analysis. WorkSetup: not specified; experience with regulated laboratory environments essential.