Manager Quality Control I - Night Shift

Amgen • Holly Springs, NC

20h

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. MANAGER QUALITY CONTROL I – NIGHT SHIFT 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 Manager for night shift support. Reporting directly to the Director of Quality Control, the Manager, Quality Control I (Night Shift) 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 12 years of quality control experience OR Associate’s degree and 10 years of quality control experience OR Bachelor’s degree and 5 years of quality control experience OR Master’s degree and 3 years of quality control experience OR Doctorate degree
• In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above.

Nice To Haves

• 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.
• 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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree