Quality Assurance Specialist - Pharma Patient Safety

Regulatory Jobs; Rochester (MI); On-site; USD 69,000 - 114,000; Full time

Benefits offered by this job

401(k) match

Comprehensive benefits

Job summary

Pfizer in the United States is seeking a Quality Assurance professional to evaluate clinical and commercial drug batches for quality and regulatory compliance. You will ensure documentation and processes meet cGMP standards and support change control and investigations as part of a cross-functional team.

The role emphasizes manufacturing readiness, inspections support, and proactive quality risk management, with relocation support and comprehensive benefits.

Qualifications

• Experience in the pharmaceutical industry and quality systems.
• Solid knowledge of current Good Manufacturing Practices (GxP).
• Ability to work in cross-functional, team environments.
• Strong written and oral communication abilities.
• Demonstrated regulatory compliance awareness.

Responsibilities

• Evaluate and review clinical and commercial drug batches for quality.
• Ensure documents meet specifications through sampling and SPC.
• Identify deviations from manufacturing and packaging standards.
• Approve investigations and oversee change control to maintain compliance.
• Contribute to project tasks and meet deadlines.
• Support inspections and quality risk management activities.

Skills

Pharma industry experience

Quality systems

cGMP knowledge

Teamwork

Communication

Regulatory compliance

Education

Bachelor's degree

Associate's degree

High school diploma

Job description

Pfizer in the United States is seeking a Quality Assurance professional to evaluate clinical and commercial drug batches for quality and regulatory compliance. You will ensure documentation and processes meet cGMP standards and support change control and investigations as part of a cross-functional team.

The role emphasizes manufacturing readiness, inspections support, and proactive quality risk management, with relocation support and comprehensive benefits.