Senior Associate Quality Control - Nights

Role Summary

Senior Associate Quality Control - Nights is a role in Amgen’s GMP-regulated QC laboratory. The position provides independent technical execution on the night shift, performing operational testing and sample support while ensuring GMP compliance, data integrity, and safety. The role reports to the Director of Quality Control and supports manufacturing, investigations, and cross-functional collaboration to meet testing timelines.

Responsibilities

• Execute QC night shift activities, working with the night shift team lead, including sample receipt, prioritization, and accurate entry into LIMS.
• Serve as a point of contact for Manufacturing during night shift operations, supporting production schedules, issue resolution, and risk escalation.
• Independently perform routine and sophisticated analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required.
• Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements.
• Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership.
• Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS).
• Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.

Qualifications

• Required: High school diploma / GED and 4 years of Quality, Analytical Testing, or GxP Computerized System validation experience
• Required: Associate’s degree and 2 years of Quality, Analytical Testing, or GxP Computerized System validation experience
• Required: Bachelor’s degree and 6 months of Quality, Analytical Testing, or GxP Computerized System validation experience
• Required: Master’s degree
• Preferred: Prior experience with hands-on analytical testing experience in chemistry, bioassay, and/or microbiology.
• Preferred: Solid understanding of data integrity, GDP, GMP, and 21 CFR Part 11 compliance.
• Preferred: Familiarity with compendial methods (e.g., USP–NF).
• Preferred: Excellent communication and organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.
• Preferred: High attention to detail, strong problem-solving skills, and ability to work autonomously during off-shift hours.