Senior Associate Quality Assurance - Thousand Oaks CA

Quality Assurance Senior Associate, Drug Substance PlantJoin Amgen's mission of serving patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives 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 areasoncology, inflammation, general medicine, and rare diseasewe 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. What you will do: Let's do this! Let's change the world! In this role as Senior Associate QA, you will be responsible for providing quality oversight to Drug Substance (DS) Cell Bank Manufacturing and Process Development (PD) laboratories at Amgen Thousand Oaks. Under general supervision, you will support and ensure compliance for Manufacturing, Facilities, and Engineering staff in their processes, procedures, and use of quality systems. You will engage directly with a diverse range of partners, establishing effective working relationships with production operators, line leads, shift supervisors, warehouse staff, facilities, maintenance, and engineering teams. The role requires local, on-site presence at the Amgen Thousand Oaks (ATO) site and is scheduled Monday through Friday, with occasional flexibility to support alternate shifts based on operational needs. Responsibilities: Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures (SOPs) and Work Instructions. Maintain a strong presence in Drug Substance (DS) areas to oversee GMP operations and quality systems. Serve as the first point of contact for quality-related production queries during DS operations. Lead, mentor, and coach Operations and support personnel on quality matters, fostering a strong Quality culture at the site. Review and approve batch production records and other GMP documentation to support daily operations. Compile and review batch records for manufactured lots in preparation for batch disposition. Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms. Collaborate effectively within a team matrix environment.