Senior Associate, Quality Assurance

Let's do this. Let's change the world. In this vital role you will: Review batch documentation for commercial and clinical products and disposition product as per Standard Operating Procedures (SOPs) Participate as QA Owner/QA Contact for Deviations, Corrective/Preventive Actions (CAPAs), Complaints, and Temperature Excursions (TEs) Review Annual Product Reviews (APRs) for commercial products Schedule, compile, review, and coordinate filing of Yearly Biologic Product Reports (YBPRs) for commercial products Review Stability Summary Reports Review Executed Batch Records Draft SOPs, Protocols, Technical Reports, and memos in support of Quality activities Run stability data reports, assess data, and issue memos in support of TEs for Amgen products Complete Quality launch milestones Develop and deliver GMP training Represent IDQ Canada from internal/external audits and inspections Represent IDQ Canada at cross-functional meetings for complaints, disposition, and launch Represent IDQ Canada as a Subject Matter Expert (SME) during internal/external audits and inspections Ensure compliance with Canadian Food and Drugs Act, Good Manufacturing Practice (GMP), and Good Distribution Practice (GDP) regulations Liaise with other divisions within the Canadian office, U.S. Head Office, and other international affiliates to exchange information to meet objectives Perform other quality tasks and projects as assigned by Manager

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.