Drug Substance Quality Assurance Specialist

Drug Substance Quality Assurance Specialist What you will do

Lets do this. Lets change the world. In this vital role within the Plant Quality Assurance organization, the Drug Substance QA Specialist provides quality oversight and compliance support for Drug Substance manufacturing operations er minimal supervision, this 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.

The Drug Substance QA Specialist will be a member of the Drug Substance Plant QA team and provide Quality oversight for Drug Substance Manufacturing and supporting Facilities & Engineering operations. Examples of Drug Substance manufacturing operations include Cell Bank, Cell Culture, and Purification. The individual will contribute to fostering a culture of Safety and Quality at Amgen Thousand Oaks. The QA Specialist provides Quality and Compliance oversight of GMP processes, procedures, investigations, and utilization of the Amgen Quality Management System.

A primary responsibility of this role is providing Quality oversight and support for deviation management processes, including investigation review and approval, root cause analysis, corrective and preventive action (CAPA) development, effectiveness verification, and timely closure of quality records. The QA Specialist partners 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.

Responsibilities also include reviewing and approving GMP documentation, observing manufacturing operations, identifying and escalating quality risks, and providing guidance to operational staff to ensure compliance with established requirements and procedures. The individual proactively identifies and communicates quality, compliance, supply, and safety risks to management and works collaboratively with stakeholders to drive timely resolution.

• Provides Quality oversight, review, and approval of major deviation investigations, ensuring events are thoroughly investigated, appropriately documented, and resolved in accordance with regulatory requirements and site procedures.
• Partners with Manufacturing, Facilities & Engineering, Quality Control, and other cross‑functional stakeholders to facilitate root cause analyses, risk assessments, corrective and preventive actions (CAPAs), and effectiveness verification activities.
• Maintains the safety of self and others, actively engages with the Amgen EHSS safety program by reporting unsafe conditions if seen and driving improvements.
• Observes GMP operations within a clean room environment and provides constructive feedback to staff and managers.
• Reviews and provides Quality approval for GMP documentation such as revisions to procedures and GMP documents, investigation reports for major deviations, change control records, corrective action/preventive action records, and other GMP records.
• Identifies and escalates significant quality, compliance, supply, and safety risks to management and supports risk‑based decision making.
• Contributes to and drives digital innovation solutions and applications in cross‑functional collaboration.
• Participates as a QA team member during regulatory inspections, third‑party audits, and internal audits.
• Ensures the Quality Management System processes are executed in accordance with established procedures.
• May author and own cGMP documents and reports.
• May also perform other duties as assigned.

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.

• Doctorate degree OR
• Masters degree and 2 years of quality experience OR
• Bachelors degree and 4 years of quality experience OR
• Associates degree and 8 years of quality experience OR
• High school diploma / GED and 10 years of quality experience