Quality Assurance Specialist
About The Position
The Quality Assurance Specialist evaluates and reviews clinical and commercial drug batches to ensure quality and verifies product and process documents against established specifications using sampling and statistical process control. The role addresses deviations from manufacturing and packaging standards, approves investigations, oversees change control activities, and ensures manufacturing and packaging records comply with Pfizer policy and cGMP standards. The specialist supports inspection readiness and regulatory and customer inspections, helps improve quality assurance systems, assists manufacturing and packaging staff with real-time compliance error detection and resolution, and leads or participates in Quality Risk Management assessments. The position also contributes to project tasks and milestones, organizes work to meet deadlines, and makes basic decisions under supervisor direction. This is a first-shift, on-premise position (0700–1530) at a penicillin manufacturing facility. The selected candidate supports manufacturing as needed and may be required to work occasional weekend shifts. Candidates must not be allergic to penicillin. Relocation support may be available based on business needs and eligibility. Candidates must have permanent U.S. work authorization; visa sponsorship is not available.
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) and 6 years of relevant experience.
- Experience in the pharmaceutical industry and Quality administered systems.
- Sound knowledge of current Good Manufacturing Practices (part of GxP).
- Ability to work effectively in a team environment, both within one's own team and interdepartmental teams.
- Effective written and oral communication skills.
- Must not be allergic to penicillin.
- 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, an Enterprise Resource Planning system, 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 and enhance work.
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 to maintain compliance 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.
- Make decisions within limited options to resolve basic problems under supervisor direction.
- Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards.
- Maintain inspection readiness and support regulatory and customer inspections.
- Improve quality assurance systems.
- Assist manufacturing and packaging staff in real-time compliance error detection and resolution.
- Lead or participate in Quality Risk Management assessments.
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.
- Eligible to participate in Pfizer’s Global Performance Plan, with a bonus target of 7.5% of base salary.
- Relocation assistance may be available based on business needs and/or eligibility.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
