Quality Control Associate - Days
Amgen
Summary
In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front-line manager. The Bioanalytics team provides analytical expertise in testing in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing.
Job description
What you will do
In this vital role you will complete and review analytical testing in our cGMP laboratory. The role will be on-site based out of Amgen Rhode Island and will work under the mentorship of the front-line manager. The Bioanalytics team provides analytical expertise in testing in-process, release and stability samples. The laboratory employs a variety of test methodologies that use sophisticated equipment including HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing.
Responsibilities include the following:
- Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
- Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
- Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations
- Operate laboratory equipment and instrumentation
- Performs review and approval of assays, documents and records
- Supports Continual Improvement initiatives
- Alerts management of quality, compliance, supply and safety risks
- Participate in laboratory investigations
- Perform general laboratory housekeeping activities
- Completes required assigned training to permit carry through of required tasks
- Performs additional duties as specified by management
Basic Qualifications
- High school diploma / GED and 2 years of Quality experience OR
- Associate's degree and 6 months of Quality experience OR
- Bachelor's degree
- Master's Degree
Preferred Qualifications
- 1-2 years' experience in HPLC/UPLC, capillary electrophoresis and general chemistry methodologies such as Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing
- Demonstrated experience in laboratory investigations, method validation, audits, QC processes
- Proven ability to interpret scientific data
- Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal direction
- Strong communication skills (both written and oral), facilitation and presentation skills
- GMP/GDP experience
Requirements
- High school diploma / GED and 2 years of Quality experience OR
- Associate's degree and 6 months of Quality experience OR
- Bachelor's degree
- Master's Degree
- 1-2 years' experience in HPLC/UPLC, capillary electrophoresis and general chemistry methodologies
- Demonstrated experience in laboratory investigations, method validation, audits, QC processes
- Proven ability to interpret scientific data
- Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal direction
- Strong communication skills (both written and oral), facilitation and presentation skills
- GMP/GDP experience
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life & 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.