Quality Assurance Specialist

Pfizer • Rochester, MI

10d • Onsite

About The Position

The Quality Assurance Specialist evaluates clinical and commercial drug batches and verifies that product, process, manufacturing, and packaging records meet established specifications, Pfizer policies, and cGMP standards. The role identifies manufacturing and packaging deviations, approves investigations, oversees change control, supports quality risk management, and helps maintain inspection readiness and quality assurance systems. The specialist also works with manufacturing and packaging staff to detect and resolve compliance errors in real time, while organizing project work and milestones within the immediate team.

This is a first-shift, on-premise position at a penicillin manufacturing facility. The employee will divide time between the office and shop floor as needed to support manufacturing and may be required to work occasional weekend shifts. Candidates must not be allergic to penicillin. Relocation support may be available. The position offers an annual base salary of $68,600 to $114,300 and eligibility for a bonus target of 7.5% of base salary.

Requirements

• Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) with 6 years of relevant experience.
• Experience in the pharmaceutical industry and in Quality-administered systems.
• Sound knowledge of current Good Manufacturing Practices (cGMP, part of GxP).
• Ability to work effectively in a team environment, including interdepartmental teams.
• Effective written and oral communication skills.
• Must not be allergic to penicillin.
• Must be authorized to work in the United States by any employer; U.S. work visa sponsorship is not available.
• Must have permanent work authorization in the United States.

Nice To Haves

• Experience at a manufacturing site.
• Experience managing and writing deviations.
• Experience in production batch record review, Enterprise Resource Planning systems, investigation of non-conformance, root cause analysis, and change control management.
• Strong problem-solving skills.
• Ability to work independently and as part of a team.
• Excellent time management and multitasking abilities.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving.

Responsibilities

• Evaluate and review clinical and commercial drug batches to ensure quality.
• Ensure product and process documents meet established specifications through sampling and statistical process control.
• Identify and address deviations from manufacturing and packaging standards.
• Approve investigations and oversee change control activities in accordance with configuration management policies.
• Contribute to project tasks and milestones, organizing work to meet deadlines.
• Apply basic team effectiveness skills within the immediate work team and resolve basic problems within limited options under supervisor direction.
• Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.
• Maintain inspection readiness and support regulatory and customer inspections.
• Help improve quality assurance systems.
• Assist manufacturing and packaging staff with real-time compliance error detection and resolution.
• Lead or participate in Quality Risk Management assessments.
• Support manufacturing as needed, including occasional weekend shifts.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Position eligible for Pfizer’s Global Performance Plan with a bonus target of 7.5% of base salary.
• Relocation support or assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level