QA Specialist: Quality Risk & Change Control Lead

Amgen SA; Juncos (PR); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision coverage

Life & disability insurance

Bonus program

Stock-based incentives

Time-off plans & site shutdown

Job summary

Amgen seeks a Specialist QA to lead Quality Risk Management and Change Control activities across GxP operations. You will drive risk assessment processes and partner with cross‑functional teams to ensure patient safety and product quality, while maintaining governance and inspection readiness.

The role requires strong analytical, communication, and technical writing skills, with experience applying QRM tools and regulatory standards in a biopharmaceutical setting.

Qualifications

• Doctorate degree required or Master’s with 2+ years QA/Manufacturing experience or Bachelor’s with 4+ years in QA/Manufacturing or Associate’s with 8+ years QA/Manufacturing or high school diploma with 10+ years QA/Manufacturing experience.

Responsibilities

• Lead and support Quality Risk Management (QRM) activities to protect patient safety and product quality.
• Manage risk assessments using FMEA, HACCP, and PrHA.
• Collaborate with cross-functional teams to embed QRM in deviations, CAPA, investigations, and change controls.
• Maintain QRM governance, documentation, procedures, and metrics.
• Analyze risk data to support risk-based decision making.
• Oversee GxP change control lifecycle from initiation to closure.
• Oversee qualification, validation, documentation, and regulatory assessments for implementation.
• Drive continuous improvement in QRM and Change Control using data trends and lessons learned.
• Support inspection readiness for QRM and Change Control with retrievable evidence and audit follow‑up actions.

Skills

Analytical

Communication

Technical writing

Cross-functional

Problem solving

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

CCMS

TrackWise

Job description

Amgen seeks a Specialist QA to lead Quality Risk Management and Change Control activities across GxP operations. You will drive risk assessment processes and partner with cross‑functional teams to ensure patient safety and product quality, while maintaining governance and inspection readiness.

The role requires strong analytical, communication, and technical writing skills, with experience applying QRM tools and regulatory standards in a biopharmaceutical setting.