Lead Specialist QA Quality Systems, Quality - 1st Shift

Role: Manager, Quality Systems, responsible for leading complex investigations, trend analysis, CAPA proposals, and investigation reporting within a GMP environment. Responsibilities: represent QA in deviation triage, facilitate cross-functional problem solving, compile and present investigation data for reviews and metrics, oversee PQRs and critical complaints, lead trending assessments, support quality system improvements, and assist with audits and inspections. Qualifications: BS degree with 10+ years’ GMP experience, thorough knowledge of cGMP, Quality Systems, and change control; strong communication and technical writing skills; adept in statistical and mathematical analyses. HighValue: GMP, cGMP standards, deviation management, investigation leadership, CAPA, trending, audit support. WorkSetup: not specified; salary range $66,000–$127,000 USD.