Senior Associate Quality Assurance

Senior Associate Quality Assurance The Senior 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 Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. What you will do 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 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 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 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 As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our 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 several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and 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 to see if this applies Equal Opportunity Employer 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, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr