Amgen Manager QC – North Carolina: Quality Control Holly Springs

Amgen has announced an exciting opportunity for experienced Quality Control professionals at its biotechnology facility in Holly Springs, North Carolina, USA. The position, Manager Quality Control I – Nights, offers an opportunity to lead night-shift QC operations, support manufacturing activities, and maintain compliance with Good Manufacturing Practices (GMP), data integrity, and laboratory quality standards.

The Amgen Manager QC position is designed for professionals with strong technical expertise, analytical testing experience, and leadership capabilities in a regulated laboratory environment. Candidates with experience in chemistry, bioassay, microbiology, laboratory information management systems, and pharmaceutical quality control may find this opportunity particularly relevant.

Interested candidates should review the qualifications, responsibilities, salary information, and application instructions below before applying through Amgen’s official careers website.

Company:
Amgen

Job Title:

Manager Quality Control I – Nights

Job : R-257054

Focus Keyword:
Amgen Manager QC

Location:

Holly Springs, North Carolina, USA

Work Location Type:
On-site

Job Category:
Quality

Work Schedule:

Wednesday–Saturday, night shift

Annual Salary Range: $–$ USD

Date Posted:
October 1, 2026

Final date to receive applications:
No fixed deadline

Official Careers Website:

Amgen is a biotechnology company established in 1980, focused on developing innovative medicines for patients living with serious illnesses. Its therapeutic areas include oncology, inflammation, general medicine, and rare diseases.

The company emphasizes scientific innovation, collaboration, and patient-focused healthcare. Joining Amgen provides professionals with an opportunity to contribute to the quality and reliability of medicines through their work in regulated manufacturing and laboratory environments.

The successful candidate will report directly to the Director of Quality Control and provide independent technical execution and shift-level leadership within a GMP-regulated laboratory.

Key responsibilities include:

• Lead and coordinate night-shift QC laboratory activities.
• Manage sample receipt, prioritization, and accurate entry into the Laboratory Information Management System (LIMS).
• Support timely analytical testing to meet manufacturing requirements.
• Ensure appropriate communication of laboratory issues and operational risks.

• Independently perform routine and complex analytical testing.
• Support testing activities in chemistry, bioassay, and/or microbiology.
• Perform STAT testing when required to support manufacturing schedules.
• Identify testing-related issues and communicate significant concerns to QC leadership.

The Amgen Manager QC role requires a strong understanding of laboratory compliance and documentation requirements.

Responsibilities include:

• Maintain compliance with current Good Manufacturing Practices (GMP).
• Follow Good Documentation Practices (GDP).
• Ensure accurate, complete, and traceable laboratory records.
• Apply relevant electronic-record requirements, including 21 CFR Part 11.
• Support investigations associated with deviations and out-of-specification (OOS) results.
• Maintain laboratory safety and established quality standards.

Candidates should be familiar with electronic systems used to manage laboratory testing, documentation, and quality processes.

The systems identified in the job description include:

• Laboratory Information Management System (LIMS)
• BIOVIA Laboratory…