Quality Assurance Specialist, cGMP Ops

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 104,000 - 141,000; Full time

Job summary

Amgen Inc. (IR) in the United States seeks a Quality Assurance Specialist to oversee cGMP/ GDP compliance during bulk drug substance operations. You will collaborate with Manufacturing, Quality Control, Supply Chain and Facilities to ensure quality standards and documentation are met.

The role requires comprehensive knowledge of quality systems, regulatory expectations, and strong communication. Amgen offers opportunities for professional growth, competitive compensation, and a robust benefits

Qualifications

• High school diploma / GED or higher with relevant QA/Manufacturing experience
• Prefer degree in Life Science or Engineering for advanced roles
• Experience with cGMP biotech manufacturing in multi-product environment is advantageous
• Experience participating in health authority inspections and audits
• Strong organizational skills and excellent written/verbal communication

Responsibilities

• Provide Quality oversight to ensure operations are manufactured, tested, stored, and distributed per cGMP and GDP
• Review and approve cGMP documents and records (BPRs, Deviations, CAPAs)
• Lead on-the-floor analytical testing oversight
• Ensure production records and test results meet procedural standards
• Identify and implement continuous improvement opportunities within processes and systems
• Support audits and regulatory inspections and liaise with authorities when needed

Skills

Root Cause Analysis

Organizational skills

Communication skills

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

Doctorate degree

Tools

MES

Delta-V

PI data historian

Job description

Amgen Inc. (IR) in the United States seeks a Quality Assurance Specialist to oversee cGMP/ GDP compliance during bulk drug substance operations. You will collaborate with Manufacturing, Quality Control, Supply Chain and Facilities to ensure quality standards and documentation are met.

The role requires comprehensive knowledge of quality systems, regulatory expectations, and strong communication. Amgen offers opportunities for professional growth, competitive compensation, and a robust benefits