Quality Control Associate - Days
About The Position
The Quality Control Associate I - Bioanalytics completes and reviews analytical testing in an on-site cGMP laboratory at Amgen Rhode Island, working under the mentorship of the front-line manager. The Bioanalytics team tests in-process, release, and stability samples using methods and equipment that include HPLC/UPLC, capillary electrophoresis, and general chemistry testing. Examples of general chemistry methodologies include Appearance, Color, Clarity, pH, Osmolality, Polysorbate, Protein Concentration, and Sub-Visible Particle testing. The role supports laboratory compliance, documentation, equipment operation, assay and record review, continuous improvement, and investigations. The associate follows safety guidelines, cGMPs, and other applicable regulatory requirements, and completes assigned training and other duties specified by management. Amgen describes a collaborative, innovative, science-based culture and offers eligible employees a Total Rewards Plan with health and welfare coverage, financial and retirement plans, work/life balance, and career development opportunities. The posted U.S. annual salary range, excluding Puerto Rico, is $62,571.90–$84,656.10. Actual salary may vary based on relevant skills, experience, and qualifications.
Requirements
- High school diploma or GED and 2 years of Quality experience; or an associate’s degree and 6 months of Quality experience; or a bachelor’s degree (the posting also lists “Master's Degree” without further detail).
Nice To Haves
- 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, and QC processes.
- Proven ability to interpret scientific data.
- Self-motivation, strong organizational skills, and ability to manage multiple tasks with minimal direction.
- Strong written and oral communication, facilitation, and presentation skills.
- GMP/GDP experience.
Responsibilities
- Follow safety guidelines, cGMPs, and other applicable regulatory requirements.
- Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks.
- Ensure facilities, equipment, materials, organization, processes, procedures, and products follow cGMP practices and other applicable regulations.
- Operate laboratory equipment and instrumentation.
- Perform review and approval of assays, documents, and records.
- Support continual improvement initiatives.
- Alert management to quality, compliance, supply, and safety risks.
- Participate in laboratory investigations.
- Perform general laboratory housekeeping activities.
- Complete required assigned training to carry out required tasks.
- Perform additional duties as specified by management.
Benefits
- Retirement and Savings Plan with generous company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Work/life balance and career development opportunities, which may include flexible work models where possible.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
