Senior Associate Quality Assurance

Role: Senior Associate Quality Assurance supporting Amgen’s Drug Product manufacturing operations. Focuses on daily oversight of GMP compliance, ensuring manufacturing processes, documentation, and quality systems meet regulatory standards in a Grade 8 clean room environment. Responsibilities include presence on the manufacturing floor, review and approval of electronic batch records, deviation assessments, SOP revisions, and maintenance documentation. Requires evaluating compliance issues and supporting quality record completion. Qualifications: High school diploma with 4+ years GMP experience or Bachelor’s degree in a related science with 6 months+ GMP experience. Preferred: Bachelor’s in Biochemistry, Biology, or Chemistry, with demonstrated GMP operation skills, project management, and experience working with Quality Systems. High-value specifics: experience in aseptic drug manufacturing, GMP documentation, and operating in a 24/7 production environment. Collaboration involves cross-functional engagement within the Plant QA organization. Work setup: shift work (days, swings, graves), including weekends, with flexibility for rotation.