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Senior QA Specialist I

Pfizer, S.A. de C.V

Andover, Minnesota, United States

Andover, Minnesota, United States

Über

Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and delivery of safe and effective products to patients. Our science and risk‑based compliant quality culture is flexible, innovative, and customer‑oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What You Will Achieve You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review commercial batches of drugs, ensuring that product and process match specifications through established sampling and statistical process control procedures. Your expertise will help identify deviations from standards in manufacturing and packaging, contributing to team goals and objectives. Your focus and ability to meet targets will help complete critical deliverables, while your communication skills will clarify complex issues and strengthen alignment across teams. How You Will Achieve It Work in a fast‑paced environment, juggling priorities as required. Review and approve laboratory and manufacturing incidents and investigations, collaborating on CAPA development and implementation. Provide quality review and oversight of site cGXP documentation to support manufacturing and site/engineering activities, ensuring compliance with regulatory agencies and Pfizer standards. Engage with a wide range of coworkers, customers and management to gather input and knowledge needed for assignments. Anticipate issues and promptly escalates them to appropriate management. Resolve moderate to complex quality issues, plan and execute work independently, consulting supervisors as needed. Apply technical and quality concepts, FDA or other regulatory guidelines, and relevant SOPs. Basic Requirements High school diploma with at least 10 years experience, or associate’s degree with 8 years experience, or bachelor’s degree with 4 years experience, or master’s with 2 years experience, or PhD with 0 + years in GMP pharmaceutical or medical device manufacturing or relevant regulatory experience. Preferred Requirements Background in biology, chemistry, engineering or related technical physical science field. Previous QA experience. Previous manufacturing and/or QC experience. Proficiency with enterprise systems: QMS, LIMS, SAP and Pfizer document repositories. Experience with quality aspects of startup of a manufacturing facility (helpful but not required). Physical/Mental Requirements Must be able to be present at the Andover site routinely as required. Work Schedule and Location First shift Monday through Friday with occasional off‑hours support. Hybrid role: 2.5 days at Andover site per week; available on site 5 days on special circumstances. Last Date to Apply June 26, 2026 Compensation and Benefits Annual base salary ranges from $99,200.00 to $165,400.00. Eligible for Pfizer’s Global Performance Plan (bonus target 12.5% of base) and share‑based long‑term incentive program. Benefits include 401(k) with matching contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and comprehensive health coverage. EEO & Employment Eligibility Pfizer is an equal‑opportunity employer. All qualified applicants are considered without regard to race, color, religion, sex, sexual orientation, age, gender identity, gender expression, national origin, disability or veteran status. This position requires permanent U.S. work authorization; no visa sponsorship is available. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws. Licensed physicians may be required to disclose recruiting expenses reimbursed by Pfizer.
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Andover, Minnesota, United States

Sprachkenntnisse

English

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