Amgen · 20 hours ago
Senior Associate Quality Control - Nights
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
4+ years expAmgen is a leading biotechnology company dedicated to serving patients with serious illnesses. The Senior Associate Quality Control plays a vital role in the Quality Control team, executing night shift activities and ensuring compliance with GMP and safety requirements in a laboratory environment.
BiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
Bachelor's degree in a scientific discipline or equivalent experience
Experience working in a GMP-regulated Quality Control laboratory with proven ability to work independently
High school diploma / GED and 4 years of Quality, Analytical Testing, or GxP Computerized System validation experience OR
Associate's degree and 2 years of Quality, Analytical Testing, or GxP Computerized System validation experience OR
Bachelor's degree and 6 months of Quality, Analytical Testing, or GxP Computerized System validation experience OR
Master's degree
Preferred
Prior experience with hands-on analytical testing experience in chemistry, bioassay, and/or microbiology
Solid understanding of data integrity, GDP, GMP, and 21 CFR Part 11 compliance
Familiarity with compendial methods (e.g., USP–NF)
Excellent communication and organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment
High attention to detail, strong problem-solving skills, and ability to work autonomously during off-shift hours
Benefits
Competitive benefits
Comprehensive Total Rewards Plans
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
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