Senior Associate Quality Control Lead - Nights

Amgen•Holly Springs, NC

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. Senior Associate Quality Control Lead - 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 lead for night shift support. Reporting directly to the Director of Quality Control, the Senior Associate, Quality Control I (Night Shift Lead) is an experienced QC professional who provides independent technical execution and shift-level leadership within a GMP-regulated laboratory environment. This role is accountable for leading night shift QC operations, ensuring accurate sample management, timely analytical testing, and 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

Nice To Haves

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.

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.