Sr Associate QA - Drug Substance Plant - (Newbury Park, CA)

A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This role supports Amgen's Quality Assurance program providing daily oversight of Drug Substance manufacturing facilities at Amgen Thousand Oaks. Under general supervision, the role provides support and compliance oversight to MANUFACTURING and F&E staff in the execution of their processes, procedures, and use of quality systems. Duties include electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of non-conformances and CAPAs.