QA Specialist - cGMP Manufacturing & Compliance

Amgen SA; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock‑based long‑term incentives

Flexible work models where possible

Retirement and Savings Plan

Job summary

Amgen is seeking a Quality Assurance Specialist to serve as a key link between Manufacturing and QA, ensuring adherence to cGMP, GDP, and company standards. You will coach staff, review records, and guide CAPAs while supporting audits and inspections across facilities.

The role emphasizes collaboration with Manufacturing, Quality Control, Supply Chain, and Facilities & Engineering to maintain product quality and regulatory readiness.

Qualifications

• Bachelor’s degree or higher in Life Science or Engineering.
• Experience with cGMP biotech manufacturing in a multi-product environment.
• Experience with Quality Management Systems: Exceptions, Change Control, Risk Management, Disposition.
• Familiarity with MES, Delta-V, PI data historian.
• Ability to build strong partnerships with client groups and influence changes to ensure compliant operations.

Responsibilities

• Provide Quality oversight to ensure products are manufactured, tested, stored and distributed per cGMP/GDP and regulations.
• Ensure facilities, equipment, materials and processes comply with Amgen requirements.
• Review and approve cGMP documents and records including CAPA and deviations.
• Author/review/approve quality documents (SOPs, risk assessments, training materials).
• Oversee on-the-floor analytical testing and ensure accurate documentation.
• Identify and implement continuous improvement opportunities in processes.

Skills

Excellent written and verbal沟m

Strong organizational skills

Problem solving

Attention to detail

Team collaboration

Education

Bachelor’s degree in Life Science or Engineering

Master’s degree

Doctorate degree

Associate’s degree

High school diploma / GED

Tools

MES

Delta-V

PI data historian

Job description

Amgen is seeking a Quality Assurance Specialist to serve as a key link between Manufacturing and QA, ensuring adherence to cGMP, GDP, and company standards. You will coach staff, review records, and guide CAPAs while supporting audits and inspections across facilities.

The role emphasizes collaboration with Manufacturing, Quality Control, Supply Chain, and Facilities & Engineering to maintain product quality and regulatory readiness.