Drug Product Quality Assurance Specialist

Role: Serve as a Drug Product Quality Assurance Specialist within Amgen's Plant Quality Assurance team, overseeing aseptic drug manufacturing and inspection activities at Thousand Oaks. Objectives include ensuring compliance with cGMP, regulatory standards, and quality systems while supporting safe and reliable operations. Responsibilities involve partnering with manufacturing, engineering, and quality teams to manage deviations, CAPAs, change controls, and document reviews; providing quality oversight of manufacturing, inspection, and validation processes; participating in audits and inspections; and driving continuous improvement and digital innovation projects. Qualifications: Bachelor’s in Science or related field with 4+ years of QA or manufacturing experience in aseptic processing; strong knowledge of contamination control, environmental monitoring, and GMP practices; excellent communication, analytical, and project management skills. Preferred: 5+ years in aseptic QA/Manufacturing, experience with deviation investigations, root cause analysis, and regulatory audits. High-value specifics: Focus on aseptic drug product manufacturing in biotech, supporting compliance for inspections and validation activities, with cross-functional interactions across manufacturing, facilities, and engineering. The role operates in a collaborative, dynamic environment with no specified travel, primarily onsite in Thousand Oaks.