Senior Associate Quality Assurance
Amgen
- Thousand Oaks, California, United States
- Thousand Oaks, California, United States
Über
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.
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Sprachkenntnisse
- English
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