QA Specialist

Role: Senior Quality Operations Specialist supporting Amgen's Final Drug Product (FDP) manufacturing at Ohio site, ensuring GMP compliance and quality standards. Responsibilities: oversee daily manufacturing activities, review and approve controlled documents, lead investigations for deviations, manage batch disposition, support audits/inspections, and drive continuous improvement initiatives. Collaborate cross-functionally with Manufacturing, QC, Engineering, and Supply Chain teams. Qualifications: Doctorate or Master's degree with 2+ years, Bachelor's with 4+ years, or equivalent experience in GMP-regulated environments; strong knowledge of GMP/GCP, validation, and quality systems. Preferred: background in sciences, digital/data sciences affinity, experience with validation documentation, problem-solving, and leadership in a regulated setting. HighValue: biologics or small molecule manufacturing, GMP compliance, validation, batch release, GMP documentation, audit readiness, cross-disciplinary collaboration, and process lifecycle management. WorkSetup: not explicitly specified but likely on-site given manufacturing oversight.