Amgen · 19 hours ago
Senior Associate Quality Control Lead - Nights
Holly Springs, NC
Full-time
Onsite
Mid, Senior Level
4+ years expAmgen is a leading biotechnology company focused on serving patients living with serious illnesses. In this role, you will provide operational leadership for the Quality Control night shift activities, ensuring compliance with GMP and managing analytical testing processes.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provide operational leadership for QC night shift activities, including sample receipt, prioritization, and accurate entry into LIMS
Serve as the primary QC point of contact for Manufacturing during night shift operations, supporting production schedules, issue resolution, and risk escalation
Independently perform routine and complex 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 demonstrated 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 serving as a shift lead, point of contact, or informal team lead within a QC laboratory
Hands-on analytical testing experience in chemistry, bioassay, and/or microbiology
Strong knowledge 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 and 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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2026-02-07
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Company data provided by crunchbase