Senior Associate Quality Assurance

Senior Associate Quality Assurance This role supports Amgen’s Quality Assurance program under the Plant QA organization, providing daily oversight of drug product manufacturing areas. Responsibilities include ensuring regulatory compliance, reviewing documentation, and supporting quality systems. What You Will Do 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 Order/Job Plans Quality support and approval of minor deviations Electronic Batch Record (MES) documentation revisions and approvals Evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion Additional Requirements 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 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 Display leadership attributes and drive improvement initiatives Solid understanding and application of aseptic behaviors and principles What You Can Expect Of Us Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts 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 Amgen is an Equal Opportunity employer and 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 applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process and to perform essential job functions. #J-18808-Ljbffr