Senior Associate Quality Control
About The Position
The Senior Associate Quality Control provides support for QC Centralized Raw Material Testing in the Wet Chemistry Laboratory at Amgen Rhode Island. The role performs routine tasks and compendial testing, including time-sensitive samples, and supports laboratory operations, documentation, review, troubleshooting, compliance, and continuous improvement. The stated schedule is Monday through Friday, 8:00 a.m. to 4:30 p.m. The role also serves as a site subject-matter expert for specialized testing, supports technical investigations and training, and owns procedures related to Raw Material testing. The position requires completion of assigned training and may include additional duties specified by management.
Requirements
- Master’s degree; or bachelor’s degree and 6 months of Quality, Manufacturing, or Operations experience; or associate’s degree and 2 years of Quality, Manufacturing, or Operations experience; or high school diploma/GED and 4 years of Quality, Manufacturing, or Operations experience.
Nice To Haves
- Experience executing analytical or biological testing according to methods and/or compendia.
- Experience with QC analytical systems and/or quality systems.
- Excellent interpersonal, written, and verbal communication skills with all levels of the organization.
- Ability to work in a team matrix environment and build relationships with partners.
- Experience leading teams or projects.
- Ability to identify, manage, and champion innovative projects to advance productivity and enable LEAN principles across functions.
- Experience auditing and defending processes, procedures, and decisions during regulatory inspections.
- Demonstrated innovative thinking and ability to transform work organizations.
- Strong technical writing skills in a highly regulated environment.
- Exposure to Operational Excellence initiatives.
- Ability to navigate ambiguity and provide structured problem solving.
- Demonstrated ability to deliver on schedule.
Responsibilities
- Ensure facilities, equipment, materials, organization, processes, procedures, and products comply with safety guidelines, cGMP practices, and other applicable regulations.
- Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks.
- Operate laboratory equipment and instrumentation.
- Perform routine raw material testing, including time-sensitive samples and compendial testing.
- Manage the Raw Material Testing Master Schedule.
- Review and approve assays, documents, records, and results in LIMS.
- Interface with CTL and enter results in LIMS.
- Serve as the site subject-matter expert for specialized testing, including auto-titration, colorimeter, FTIR, and SOR.
- Support troubleshooting and problem solving.
- Alert management to quality, compliance, supply, and safety risks.
- Support TRAs and deviations as a technical subject-matter expert.
- Support and drive continuous improvement initiatives.
- Serve as an instructor on several specialty tests.
- Own documentation for Raw Material testing procedures.
- Complete assigned training required to perform job tasks.
- Perform additional duties specified by management.
Benefits
- Health and welfare plans for staff and eligible dependents
- Retirement and Savings Plan with generous company contributions
- Group medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- 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
- Flexible work models where possible
- Career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
