Specialist Quality Assurance

Career Category Quality Job Description Join 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 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. Specialist Quality Assurance What you will do Let s do this. Let s change the world. In this vital role you will provide quality assurance support to the PQ organization as a subject matter expert of quality systems and records. In this team-based role you will directly add to the success of the Product Quality team by collaborating within PQ and with diverse levels in functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations. The QA Specialist will use technical abilities and knowledge of QMS processes, procedures, and regulations to lead and deliver quality assurance responsibilities while owning, reviewing, and/or approving Product Quality records and documentation including: product specifications, in-process control specifications, specification technical reports, annual product reviews (APRs), international expansion forms, change control records, appendix docs (data sheets and data analysis), Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols, analytical comparability reports, and procedures. Additionally, this role will approve commercial variation records (GDCR), and may provide training to other staff. Responsibilities: As a team member you will use your technical abilities to execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and may include additional business process support for APRs and site audits, as needed. The QA specialist may also support managing products in the annual product review cycles at Amgen. • Provide QA Systems expertise and QA support to the Product Quality organization (PQ and Stability) by working within a team environment. • Provide Product Quality QA support to one or more of Amgen's clinical and commercial products by working directly with Product Quality Leaders and Principal Product Quality Leaders on QA tasks. • Responsible for QA tasks in support of both clinical and commercial Product Quality Leaders, including ownership, QA review and approval of documents (Protocols, Reports, Specifications, IPC s, Annual Product Review, etc.), and execution of transactions (Owner and/or QA Contact) in relevant GMP systems (VEEVA CDOCS, Change Control, Deviation/CAPA, etc.) and may include additional business process support. • Support of audits/inspections, APR management, and other processes as required. • Supporting/facilitating continuous improvement initiatives intended to increase Quality systems efficiencies within and outside of the PQ organization. • Interact with other functional areas within Amgen such as Corporate Quality, International Quality, Quality Control, Regulatory, Process Development, Site Quality Assurance, Supply Chain, Manufacturing, etc. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications. Basic Qualifications: • Doctorate degree Or • Master s degree and 2 years of Quality, Operations, Scientific, or Manufacturing experience Or • Bachelor s degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience Or • Associate s degree and 8 years of Quality, Operations, Scientific, or Manufacturing experience Or • High school diploma / GED and 10 years of Quality, Operations, Scientific, or Manufacturing experience Preferred Qualifications: • Understanding of pharmaceutical sciences, quality, compliance and regulatory requirements associated with biologics and/or synthetics manufacturing and QC testing for clinical and/or commercial products. • General understanding of biopharmaceutical bulk and drug product development and manufacturing and general knowledge of cGMP s. • Previous experience using VEEVA, Trackwise and other Amgen quality systems. • Quality Assurance experience reviewing and approving cGMP documentation (Protocols, Reports, Spe...