Pharma Quality Assurance Specialist | Impact & Compliance

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

Benefits offered by this job

401(k) with Pfizer Matching Contrib.

Pfizer Retirement Savings Contribution

Paid vacation

Holidays and personal days

Health benefits: medical, dental, and视

Job summary

Pfizer in the United States operates a penicillin manufacturing facility in a first shift role. The candidate will evaluate batches, ensure QC documentation meets specifications, and support change control and investigations to maintain cGMP compliance.

This position requires a degree or equivalent experience in pharma and strong teamwork, communication, and problem-solving skills. Relocation assistance may be available; on-premise work location and compliance with Pfizer policies are expected.

Qualifications

• Bachelor's degree (or equivalent) in a relevant field.
• Experience in pharmaceutical industry and quality administered systems.
• Strong knowledge of current Good Manufacturing Practices (GxP).
• Ability to work in cross-functional teams and communicate effectively.
• Experience with deviation management and investigations is a plus.

Responsibilities

• Evaluate and review clinical and commercial drug batches for quality.
• Ensure documents meet specifications through sampling and statistical process control (SPC).
• Identify deviations from manufacturing and packaging standards.
• Approve investigations and oversee change control activities.
• Contribute to projects and meet milestones.
• Learn and apply basic team effectiveness skills within the work group.
• Make decisions within limited options to resolve basic problems under supervision.
• Ensure manufacturing/packaging records conform to Pfizer policy and cGMP standards.
• Maintain inspection readiness and support regulatory inspections.

Skills

Quality Assurance

GxP compliance

cGMP knowledge

Team collaboration

Written and verbal communication

Problem solving

Change control

Risk assessment

Audit support

Documentation review

Education

Bachelor's degree

Associate degree with 4 years relevant experience

High school diploma with 6 years relevant experience

Tools

ERP (Enterprise Resource Planning)

CAPA systems

Job description

Pfizer in the United States operates a penicillin manufacturing facility in a first shift role. The candidate will evaluate batches, ensure QC documentation meets specifications, and support change control and investigations to maintain cGMP compliance.

This position requires a degree or equivalent experience in pharma and strong teamwork, communication, and problem-solving skills. Relocation assistance may be available; on-premise work location and compliance with Pfizer policies are expected.