Sr Associate Quality Control I
Amgen
Summary
In this vital role you perform testing and assist with managing the Quality Control Bioassay laboratory. The Specialist, Quality Control Bioassay will report directly to the Senior Manager of Quality Control Bioassay. This role may manage bioassay staff.
Job description
What you will do
In this vital role you perform testing and assist with managing the Quality Control Bioassay laboratory. The Specialist, Quality Control Bioassay will report directly to the Senior Manager of Quality Control Bioassay. This role may manage bioassay staff.
Under minimal supervision, the successful candidate will support the QC organization by:
- Assisting with planning and execution of equipment installation and qualification within the Bioassay lab to support startup.
- Responsible for operating QC bioassay analytical testing for biologic products which includes ELISA and cell-based methods.
- Leading transfer, qualification, and/or validation for the complex biologic procedures.
- Author, revise, and review documents and reports including SOPs, safety assessments, methods, trend reports, qualification/validation summary reports, technical reports, and method assessments.
- Assisting with planning, scheduling, and execution of daily activities.
- Working with external partners to ensure successful transfer and release of and stability testing.
- Supporting all operations of the Bioassay lab including the ordering of supplies, maintaining of equipment and lab spaces.
- Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
- Own, manage, and participate in deviations, CAPAs, and cross functional investigations.
- Training of junior staff in bioassay techniques and assays.
- Assisting with general lab setup and 5S.
- Support routine activities over the weekends and Amgen holidays as needed
What we expect of you
The Specialist Quality Control Bioassay professional we seek is a dynamic, flexible, and driven individual with these qualifications.
Basic Qualifications
- High school/GED + 4 years of Quality Analytical testing experience OR
- Associate's + 2 years of Quality Analytical testing experience OR
- Bachelor's + 6 months of Quality Analytical testing experience OR
- Master's
Preferred Qualifications
- Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
- Degree in immunology, Biology, Biochemistry, or related scientific field.
- Experience with cell-based methods and ELISA's, with strong data analysis skills.
- Experience with equipment validation.
- Strong knowledge of aseptic technique.
- Strong written and verbal communication skills, including technical writing and technical presentations.
- Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer.
Requirements
- High school/GED + 4 years of Quality Analytical testing experience OR
- Associate's + 2 years of Quality Analytical testing experience OR
- Bachelor's + 6 months of Quality Analytical testing experience OR
- Master's
- Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements
- Degree in immunology, Biology, Biochemistry, or related scientific field
- Experience with cell-based methods and ELISA's, with strong data analysis skills
- Experience with equipment validation
- Strong knowledge of aseptic technique
- Strong written and verbal communication skills, including technical writing and technical presentations
- Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer
Benefits
- Health Insurance
- Dental Coverage
- Vision Coverage
- Retirement and Savings Plan
- Life Insurance
- Disability Insurance
- Flexible Spending Accounts
- Annual Bonus Program
- 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.