Specialist Quality Assurance
Amgen
August 31, 2026
Remote friendly (United States)
United States
Corporate Functions
Specialist Quality Assurance
What You Will Do
Provide QA support to the Product Quality (PQ) organization as a subject matter expert of quality systems and records. Collaborate across PQ and functional areas (Supply Chain, Manufacturing, QC, QA, Regulatory, Quality Engineering, International Quality, Process Development) on projects, issue resolution, and investigations. Own, review, and/or approve Product Quality records and documentation, including: product specs, in-process control specs, specification technical reports, APRs, international expansion forms, change control records, appendix docs, Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols/reports, and procedures. Approve commercial variation records (GDCR) and may provide training.
Responsibilities
- Execute GMP transactions in systems (e.g., Veeva CDOCs, Trackwise) and support APR/site audits.
- Support clinical and commercial products’ QA tasks, including document review/approval and GMP system transactions (owner/QA contact).
- Support audits/inspections and APR management.
- Facilitate continuous improvement to increase Quality systems efficiencies.
Basic Qualifications
- Doctorate OR Master’s + 2 years OR Bachelor’s + 4 years OR Associate’s + 8 years OR HS/GED + 10 years in Quality/Operations/Scientific/Manufacturing.
Preferred Qualifications
- Biologics/synthetics cGMP/QC compliance knowledge; biopharma development and cGMP basics.
- Experience with Veeva, Trackwise; reviewing/approving cGMP documentation.
- Investigation skills (Deviations/CAPAs/EVs), change control ownership, variation management.
- Cross-functional/matrix experience, project management, strong communication, Senior Mgmt interaction, strong organization.
Benefits (Total Rewards Plan—based on eligibility)
Health/welfare plans, retirement savings contributions, bonus/incentives, stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
Apply now. No application deadline; applications are accepted until a sufficient number is received or a candidate is selected. Sponsorship not guaranteed.
What You Will Do
Provide QA support to the Product Quality (PQ) organization as a subject matter expert of quality systems and records. Collaborate across PQ and functional areas (Supply Chain, Manufacturing, QC, QA, Regulatory, Quality Engineering, International Quality, Process Development) on projects, issue resolution, and investigations. Own, review, and/or approve Product Quality records and documentation, including: product specs, in-process control specs, specification technical reports, APRs, international expansion forms, change control records, appendix docs, Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols/reports, and procedures. Approve commercial variation records (GDCR) and may provide training.
Responsibilities
- Execute GMP transactions in systems (e.g., Veeva CDOCs, Trackwise) and support APR/site audits.
- Support clinical and commercial products’ QA tasks, including document review/approval and GMP system transactions (owner/QA contact).
- Support audits/inspections and APR management.
- Facilitate continuous improvement to increase Quality systems efficiencies.
Basic Qualifications
- Doctorate OR Master’s + 2 years OR Bachelor’s + 4 years OR Associate’s + 8 years OR HS/GED + 10 years in Quality/Operations/Scientific/Manufacturing.
Preferred Qualifications
- Biologics/synthetics cGMP/QC compliance knowledge; biopharma development and cGMP basics.
- Experience with Veeva, Trackwise; reviewing/approving cGMP documentation.
- Investigation skills (Deviations/CAPAs/EVs), change control ownership, variation management.
- Cross-functional/matrix experience, project management, strong communication, Senior Mgmt interaction, strong organization.
Benefits (Total Rewards Plan—based on eligibility)
Health/welfare plans, retirement savings contributions, bonus/incentives, stock-based long-term incentives, time-off, and flexible work models where possible.
Application Instructions
Apply now. No application deadline; applications are accepted until a sufficient number is received or a candidate is selected. Sponsorship not guaranteed.