Senior Associate Quality Assurance
Amgen
Summary
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 Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements.
Job description
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
- 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
- Responsibilities will include 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
Requirements
- 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
- 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
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Retirement and savings plan
- Flexible spending accounts
- Discretionary annual bonus
- Stock-based long-term incentives
- Paid time-off
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.