Senior Associate Quality Assurance
Amgen
Summary
The role is fully onsite in Thousand Oaks, CA, and requires the ability to lift 30+ pounds and pass a vision assessment for inspection work. Candidates must be comfortable working with raw materials and components, mainly chemicals, and may have to work in the sampling suite for extended periods of time. Previous experience with GMP is a plus but not mandatory, as training can be provided. Candidates of all backgrounds and experience levels will be considered if they demonstrate the right attitude and interest in the role.
Job description
Key Responsibilities
- Responsible for sampling and inspection of raw materials and components
- Performing quality review of documentation for assigned functions (e.g. equipment and maintenance records)
- Lead small projects and continuous improvement initiatives
- Operation and maintenance of instruments and equipment associated with sampling, e.g., Toledo balance, drum lift, pallet jack, etc.
- Maneuvering of large drums required
- Responsible for the maintenance of training records, recording and computing data
- Ability to maneuver 50+ pounds
- General understanding of aseptic techniques, cGMPs, gowning, sampling procedures and safety guidelines
- Work as a team player and/or independently
- Multi-task and basic problem-solving skills
- Excellent communication, both written and verbal
- Proficient computer skills (i.e. documentation systems, databases and spreadsheets)
- Strong attention to detail and effective time management skills
Basic Qualifications
- High school/GED + 4 years of Quality experience OR
- Associate’s + 2 years of Quality experience OR
- Bachelor’s degree and 6 months of Quality or Operations experience
- Master's degree
Preferred Qualifications
- Bachelors degree
- Prior GMP experience
- Previous experience using production/warehouse equipment
- Familiarity with inspection equipment
Requirements
- High school/GED + 4 years of Quality experience OR
- Associate’s + 2 years of Quality experience OR
- Bachelor’s degree and 6 months of Quality or Operations experience
- Master's degree
- Ability to lift 30+ pounds
- Ability to maneuver 50+ pounds
- Pass a vision assessment for inspection work
- General understanding of aseptic techniques, cGMPs, gowning, sampling procedures and safety guidelines
- Excellent communication, both written and verbal
- Proficient computer skills (i.e. documentation systems, databases and spreadsheets)
- Strong attention to detail and effective time management skills
- Multi-task and basic problem-solving skills
- Work as a team player and/or independently
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Retirement and savings plan
- Flexible spending accounts
- Annual bonus program
- Stock-based long-term incentives
- Time-off plans
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.