Drug Product Quality Assurance Specialist

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year.

Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity‑related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award‑winning culture is collaborative, innovative, and science‑based.

If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

In this vital role within the Plant Quality Assurance organization the Drug Product QA Specialist provides Quality oversight to operational activities associated with the aseptic Drug Product manufacturing and Inspection areas at Amgen, Thousand Oaks. Under minimal supervision, the role ensures adherence to cGMP requirements, quality systems, and regulatory expectations while partnering closely with Manufacturing, Facilities & Engineering, and other cross‑functional teams to support safe, compliant, and reliable operations.

Let’s do this. Let’s change the world.

• Ensuring timely delivery and completion of records within our Quality Management System, including Deviations, Corrective Actions and Preventive Actions (CAPAs), Change Controls and document revision, review and approval.
• Partnering closely with Manufacturing, Facilities & Engineering, Quality Control, and other cross‑functional stakeholders to ensure events are thoroughly investigated, appropriately documented, and resolved in accordance with regulatory requirements and site procedures.
• Evaluating compliance and operational issues, providing recommendations and oversight, and ensuring progress of quality records to completion.
• Representing the B20 Quality function in projects as necessary to achieve departmental and plant goals and working in a dynamic cross functional environment.

• Partners with Manufacturing, Facilities & Engineering, Quality Control, and other cross‑functional stakeholders to facilitate root cause analyses, risk assessments, CAPAs, and effectiveness verification activities.
• Participates in and provides quality oversight for quality records including Deviations, Change Controls, and CAPAs, assuring adherence to procedural requirements and regulatory expectations.
• Partners with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
• Provides Quality Oversight of the manufacturing facility including manufacturing operations, inspection and utilities, as well as nonroutine activities such as process and product validation.
• Provides quality expertise and guidance to operational staff and within cross functional Amgen teams.
• Reviews and approves controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports.
• Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices,…