Senior QA Specialist: GMP & Quality Systems

Amgen SA; Northern (KY); Hybrid; USD 110,000 - 145,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, dental and vision coverage

Job summary

Amgen seeks a Specialist Quality Assurance to provide QA support to the Product Quality organization. You’ll own and review product quality documents, manage change controls, CAPAs, and deviations, and participate in audits and inspections across clinical and commercial products.

You will work with teams across Supply Chain, Manufacturing, Quality Control, Regulatory, and Process Development to ensure compliance and continuous improvement in GMP systems.

Qualifications

• Doctorate, Master’s, Bachelor’s, Associate’s, or High school with related experience in quality/manufacturing.
• Quality, regulatory knowledge in biologics/drug product development and manufacturing.
• Experience using VEEVA, Trackwise and related Amgen quality systems.
• Experience reviewing and approving GMP documentation (Protocols, Reports, SOPs).
• Strong investigation and CAPA/EV experience.

Responsibilities

• Provide QA systems expertise to Product Quality and Stability teams.
• Support QA tasks across clinical and commercial products.
• Own/QA review and approval of documents and transactions in GMP systems.
• Assist in audits/inspections and APR management.
• Drive continuous improvement of quality systems.
• Collaborate with cross-functional teams (Regulatory, Supply Chain, Manufacturing).

Skills

QA systems

Investigation skills

Cross-functional collaboration

Project management

Communication skills

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

VEEVA CDOCS

Trackwise

Quality systems

Job description

Amgen seeks a Specialist Quality Assurance to provide QA support to the Product Quality organization. You’ll own and review product quality documents, manage change controls, CAPAs, and deviations, and participate in audits and inspections across clinical and commercial products.

You will work with teams across Supply Chain, Manufacturing, Quality Control, Regulatory, and Process Development to ensure compliance and continuous improvement in GMP systems.