Specialist Quality Assurance
Amgen
August 26, 2026
Remote friendly (United States)
United States
Operations
Specialist Quality Assurance
What You Will Do / Responsibilities:
- Provide Quality Assurance (QA) Systems expertise and QA support to Product Quality (PQ and Stability).
- Provide Product Quality QA support to one or more clinical/commercial products; partner with Product Quality Leaders.
- Own, review, and approve cGMP Product Quality records/documentation (e.g., protocols, reports, specifications, IPCs, APRs, change control records, Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols/reports, procedures).
- Execute QA transactions in GMP systems (e.g., Veeva CDOCs, Trackwise, change control, deviation/CAPA systems) and support APR/site audit processes.
- Support audits/inspections and APR management; support annual product review cycle product management.
- Facilitate continuous improvement to increase Quality systems efficiencies.
- Interact cross-functionally with Corporate/International Quality, Quality Control, Regulatory, Process Development, Site QA, Supply Chain, Manufacturing, etc.
Qualifications:
Basic:
- Doctorate; or Master’s + 2 years; or Bachelor’s + 4 years; or Associate’s + 8 years; or HS diploma/GED + 10 years in Quality/Operations/Scientific/Manufacturing.
Preferred:
- Biologics/synthetics quality, compliance, and regulatory understanding; cGMP knowledge.
- Experience with Veeva, Trackwise, and Amgen quality systems.
- cGMP documentation review/approval experience.
- Strong investigation skills (Deviations/CAPAs/EVs) and/or change control ownership.
- Variation management experience; cross-functional matrix teamwork; project management.
- Excellent communication (written/verbal, facilitation/presentation) and ability to interact with senior management.
Benefits:
- Comprehensive benefits package (medical/dental/vision, life/disability, retirement & savings, flexible spending), bonus/incentives, stock-based long-term incentives, time-off plans, and possible flexible work models.
Application instructions:
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient candidates are received or a selection is made. Sponsorship is not guaranteed.
What You Will Do / Responsibilities:
- Provide Quality Assurance (QA) Systems expertise and QA support to Product Quality (PQ and Stability).
- Provide Product Quality QA support to one or more clinical/commercial products; partner with Product Quality Leaders.
- Own, review, and approve cGMP Product Quality records/documentation (e.g., protocols, reports, specifications, IPCs, APRs, change control records, Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols/reports, procedures).
- Execute QA transactions in GMP systems (e.g., Veeva CDOCs, Trackwise, change control, deviation/CAPA systems) and support APR/site audit processes.
- Support audits/inspections and APR management; support annual product review cycle product management.
- Facilitate continuous improvement to increase Quality systems efficiencies.
- Interact cross-functionally with Corporate/International Quality, Quality Control, Regulatory, Process Development, Site QA, Supply Chain, Manufacturing, etc.
Qualifications:
Basic:
- Doctorate; or Master’s + 2 years; or Bachelor’s + 4 years; or Associate’s + 8 years; or HS diploma/GED + 10 years in Quality/Operations/Scientific/Manufacturing.
Preferred:
- Biologics/synthetics quality, compliance, and regulatory understanding; cGMP knowledge.
- Experience with Veeva, Trackwise, and Amgen quality systems.
- cGMP documentation review/approval experience.
- Strong investigation skills (Deviations/CAPAs/EVs) and/or change control ownership.
- Variation management experience; cross-functional matrix teamwork; project management.
- Excellent communication (written/verbal, facilitation/presentation) and ability to interact with senior management.
Benefits:
- Comprehensive benefits package (medical/dental/vision, life/disability, retirement & savings, flexible spending), bonus/incentives, stock-based long-term incentives, time-off plans, and possible flexible work models.
Application instructions:
- Apply via careers.amgen.com. No application deadline; applications accepted until sufficient candidates are received or a selection is made. Sponsorship is not guaranteed.