Senior Associate Quality Assurance

Overview Join Amgen’s Mission of Serving Patients. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, Amgen has helped pioneer biotech in the fight against serious diseases. We focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. We aim to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions, delivering innovative medicines to help people live longer, fuller lives. Our culture is collaborative, innovative, and science-based. Senior Associate Quality Assurance What You Will Do The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization. You will provide daily oversight of the Drug Product manufacturing areas and ensure execution of processes, procedures, and quality systems align with regulatory requirements. Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning), 100% Manual Visual inspection support, ASP/AQL performance, and QA oversight assessments Electronic batch review GMP document (SOPs/FORMs) revision review/approval Review and approval of electronic maintenance documentation, work orders, and job plans Quality support and approval of minor deviations Electronic Batch Record (MES) documentation revisions and approvals Evaluate compliance issues, provide recommendations, and ensure progress of quality records to completion 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 8 hrs to 12 hrs depending on rotation (Days, Swings, Graves) Shift rotations will be required (Days, Swings, Graves) to support the 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 OR 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 and independently Leadership attributes and drive improvement initiatives Solid understanding and application of aseptic behaviors and principles What You Can Expect Of Us We support your professional and personal growth and well-being. From our competitive benefits to a collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on factors including but not limited to relevant skills, experience, and qualifications. Benefits & Total Rewards In addition to base salary, Amgen offers a Total Rewards Plan with eligible health and welfare plans, financial plans, retirement savings, work/life balance, and career development opportunities. A comprehensive employee benefits package including a Retirement and Savings Plan with company contributions, medical/dental/vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible (refer to the Work Location Type in the job posting) Other Information Apply now and make a lasting impact with the Amgen team. careers.amgen.com Amgen is an Equal Opportunity employer. We will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. We will provide reasonable accommodations to participate in the job application or interview process as needed. Contact us to request accommodation. Application deadline: Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate. Sponsorship for this role is not guaranteed. #J-18808-Ljbffr