Specialist QA 1

Role: Quality Assurance Specialist responsible for Plant Quality Assurance (PQA) at Amgen, ensuring manufacturing compliance and product quality in cell culture and bioprocessing environments. Objectives include real-time oversight of manufacturing operations, facilitating deviations, and supporting regulatory readiness. Responsibilities involve reviewing and approving cGMP processes, documentation, CAPAs, and validation protocols; guiding manufacturing, QC, and engineering teams on compliance; and supporting audits and inspections. Qualifications: High school diploma with 10+ years, or relevant degree with 4+ years in biotech or manufacturing Quality, Process Development, or Engineering; Life Science or Engineering background preferred. Skills include knowledge of cGMP, Quality Management Systems, automation (MES, Delta-V), and root cause analysis; strong collaboration and problem-solving abilities essential. High-Value: Biotech manufacturing (cell culture, protein purification), cGMP compliance, QA oversight, regulatory inspections, and cross-functional collaboration. Work setup details and travel expectations are not specified.