Amgen Sr. Associate QA in Thousand Oaks, California
Amgen is seeking a Senior Associate Quality Assurance at its corporate campus located in Thousand Oaks, CA to join the Supplier Quality Management-Materials Team structuring and evolving its Genetics Strategy. The Senior Associate will report to the Senior Manager Quality Assurance and will be responsible for raw material qualification
Supplier Quality Management (SQM) is an organization within Corporate Quality Assurance. SQM is responsible for managing the quality relationship with raw material suppliers
Key responsibilities for the Senior Associate include:
Develop, revise and implements raw material specifications and procedures that comply with regulatory requirements
Responsible for initial raw material qualification, Raw material reduce testing qualification, raw material commercialization, and second sourcing efforts
Participates and support raw material risk management
Responsible for ensuring data integrity requirements are captured and met for suppliers and raw materials.
Responsible for supporting and reviewing animal derived assessment to support product fillings
Bachelor's degree and 2 years of Quality or Operations experience
Associate's degree and 6 years of Quality or Operations experience
High school diploma / GED and 8 years of Quality or Operations experience
Previous experience in Supplier Quality Management
Previous experience working with the following systems; EDMQuality, SAP, Change Control, & PLM
Ability to interact with regulatory agencies Working knowledge of major pharmacopeias.
Ability to working cross functional and globally with; Process development, corporate manufacturing, supply chain, & All Amgen sites
Experience in working with and/or knowledge of how raw materials are used in Amgen manufacturing processes
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.