Senior Associate Quality Assurance / Aseptic Coach

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. Senior Associate Quality Assurance / Aseptic Coach What you will do Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our 24/7 Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. Duties include but are not limited to:     • Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments.     • Responsible for performing real-time aseptic oversight and coaching of filling activities on the manufacturing floor.     • Support real-time troubleshooting and triage with quality and aseptic compliance.     • Support quality related decision making involving non-routine interventions and documentation.     • Electronic batch record review.     • GMP Document (SOPs/FORMs) revision review/approval.     • Review and approval of electronic Maintenance documentation Work Order/Job Plans.     • Quality support and approval of minor deviations.     • Electronic Batch Record (MES) documentation revisions and approvals.     • Support predominantly second/third shift work. Additionally:     • Must be flexible with shift work (including weekends) and comfortable with gowning requirements to support 24/7 production in a Grade 8 (Clean Room) Drug Product filling facility.     • Shifts may vary from 8hrs to 12hrs depending on rotation (Days, Swings, Graves)     • Shift rotations will be required (Days, Swings, Graves) to support production schedule. What we expect of you: We are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek is an employee with these qualifications. Basic Qualifications:     • High school/GED + 4 years of GMP experience OR     • Associate’s + 2 years of GMP experience OR     • Bachelor’s + 6 months of GMP experience     • Master's Preferred Qualifications:     • Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field     • Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices     • Experience managing projects through to completion meeting timelines.     • Ability to evaluate documentation and operations according to company procedures.     • Experience working with Quality Systems     • Strong organizational skills and ability to manage multiple tasks at one time     • Effective communication skills (both written and verbal)     • Demonstrated ability to work as both a team player