Drug Product Quality Assurance Specialist

Amgen seeks a Drug Product Quality Assurance Specialist to provide quality oversight for aseptic drug product manufacturing operations at its Thousand Oaks facility. The role ensures compliance with cGMP requirements and regulatory standards while managing quality records, investigations, and cross-functional improvement initiatives.

Responsibilities

• Partner with Manufacturing, Facilities, Engineering, and Quality Control on root cause analyses, risk assessments, CAPAs, and effectiveness verification
• Provide quality oversight of Deviations, Change Controls, and CAPAs to ensure procedural and regulatory compliance
• Review and approve controlled documents including Standard Operating Procedures, Protocols, and Reports
• Conduct quality oversight of manufacturing operations, inspection areas, utilities, and nonroutine validation activities
• Participate in internal and external audits and directly interact with regulatory agencies during inspections

Requirements

• Doctorate degree, or Master's degree with 2 years quality experience, or Bachelor's degree with 4 years quality experience
• Strong experience with deviation investigations, root cause analysis, and CAPA development
• Knowledge of contamination control, environmental monitoring, and utility systems in GMP manufacturing
• Excellent written and verbal communication skills and ability to work in matrix environments
• Experience with problem-solving tools, audit participation, and regulatory inspections
• Project management and cross-functional team leadership capabilities