Senior Associate Quality Control - Nights

Amgen•Holly Springs, NC

23h

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Quality Control - Nights What you will do Let’s do this. Let’s change the world. In this vital role you will play a key role in the Quality Control team as the Senior Associate QC night shift support. Reporting directly to the Director of Quality Control, the Senior Associate, Quality Control I (Night Shift) is an expert QC professional who provides independent technical execution within a GMP-regulated laboratory environment. This role is accountable for operational testing and sample support on the QC night shift operations team ensuring sustained compliance with GMP, data integrity, and safety requirements.

Requirements

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
Experience working in a GMP-regulated Quality Control laboratory with proven ability to work independently.

Nice To Haves

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.

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.