Sr Associate Quality Control

Role Summary

Sr Associate Quality Control will perform and review analytical testing in Amgen's cGMP laboratory at the Rhode Island site, under the mentorship of the front-line manager. The Bioanalytics team provides analytical support for in-process, release, and stability samples, using methods such as HPLC/UPLC, capillary electrophoresis, and general chemistry measurements.

Responsibilities

• 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

Qualifications

• Required: High school diploma / GED and 4 years of Quality or Operations experience OR Associate’s degree and 2 years of Quality or Operations experience OR Bachelor’s degree and 6 months of Quality or Operations experience OR Master's degree
• Preferred: 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
• Preferred: Demonstrated experience in laboratory investigations, method validation, audits, QC processes
• Preferred: Ability to interpret scientific data
• Preferred: Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal direction
• Preferred: Strong communication skills (both written and oral), facilitation and presentation skills
• Preferred: GMP/GDP experience