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Amgen Sr. Specialist QA in Thousand Oaks, California

The Sr. Specialist will assume the responsibility of the Amgen Thousand Oaks (ATO) Site Subject Matter Expert (SME) for the Change Control and Risk Management Quality Systems. Additionally, the role may include cross training to support Supplier Oversight, Recall & Recovery, and other Quality Systems. The following is a high-level summary of the role:

  • ATO Site SME for the Change Control Quality System

  • ATO Site SME for the Risk Management Quality System

  • Support of additional Quality Systems at ATO as necessary

The individual will be responsible for, but not limited to:

  • Actively represent ATO on the applicable Global Quality System Network

  • Provide input and influence global decision related to the Quality Systems

  • Monitor and drive improvements to the health of the Quality Systems

  • Provide leadership updates regarding the health and initiatives relating to the Quality Systems

  • Provide change management to ATO staff for changes relating to the Quality Systems

  • Provide guidance to change control and risk assessment owners when records are needed and the appropriate methodology

  • Presentation of the Quality System in site inspections and audits

  • Author and own the Quality Risk Management Plan and Quality Risk Catalog

  • Ensure site procedures relating to the quality systems are aligned with multisite procedures.

  • Perform applicable Quality System site procedure gap assessments, as applicable.

Desired skills/behaviors include:

  • Interpersonal skills to effectively influence global decision making and manage change with Quality System Users

  • Leadership skills to drive improvements to the Quality Systems

  • Ability to clearly communicate status of the health of the Quality Systems

This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality, Process Engineering, Process Development, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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