Specialist Quality Assurance Drug Product - Thousand Oaks CA
MSCCNThousand Oaks, California, United States
Posted March 25, 2026
Full Time
About the Company
Military Spouse Jobs (MSCCN) is a 501(c)(3) nonprofit dedicated to empowering military families through comprehensive employment support. The organization offers free, one‑to‑one job placement assistance, live on‑demand training, resume development, and career coaching to military spouses, caregivers of wounded service members, war‑wounded veterans, and National Guard and Reserve families. By tailoring services to the unique challenges of military life—such as frequent relocations and caregiving responsibilities—MSCCN delivers personalized solutions that help clients secure stable, fulfilling careers. Its commitment to accessibility, community partnership, and evidence‑based career resources distinguishes it as a leading advocate for workforce inclusion among military families.
Job Description
Support the Plant Quality Assurance program providing daily oversight of operational activities associated with and supporting the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Ensure timely delivery and completion of records within our QMS and provide quality expertise and guidance to operational staff.
Requirements
- Partner with colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain a strong culture of Quality and Safety
- Provide Quality support to Tech Transfers into the Drug Product facility
- Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities
- Participate in and provide quality oversight for quality records including Deviations, Change Controls, and CAPAs
- Perform impact assessments as part of change controls impacting production or QA processes
- Review and approve controlled documents, including but not limited to Standard Operating Procedures, Protocols and Reports
- Ensure that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls
- Contribute to and drive continuous improvement projects in cross-functional collaboration
- Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals
- Contribute to and drive digital innovation solutions and applications in cross-functional collaboration
Benefits
- Retirement Plan
- 401k Matching
