Senior Quality Assurance Specialist

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals. Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. What You Will Achieve Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications. Conduct rigorous sampling and statistical process control procedures to identify deviations from standards. Approve investigations and change control activities to maintain compliance with configuration management policies. Contribute to moderately complex projects, managing time effectively and developing short-term work plans. Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts. Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards. Required Qualifications Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate’s degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience. Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards. Strong critical thinking skills. Ability to work effectively within own team and interdepartmental teams. Good working knowledge of Microsoft Excel and Word. Proactive approach to problem‑solving. Preferred Qualifications Experience in quality administered systems. Strong organizational skills and attention to detail. Experience with regulatory compliance and documentation. Ability to mentor and review the work of other colleagues. Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use. Physical & Mental Requirements Must be able to aseptically gown. This is a penicillin manufacturing facility. All candidates applying must NOT be allergic to penicillin. Able to lift 25-30 lbs. Other Job Details Location: Work On Premise Salary: $82,700.00 to $137,900.00 per year, eligible for Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. Benefits include a 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, and health benefits (medical, prescription drug, dental and vision coverage). Relocation assistance may be available based on business needs and/or eligibility. Last Date to Apply: July 27, 2026 All candidates must be authorized to be employed in the U.S. by any employer; U.S. work visa sponsorship (such as TN, O-1, H-1B) is not available for this role now or in the future. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. Subject to further legal review and statutory or regulatory clarification, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. If you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments are reported to the government. For questions regarding this matter, please contact your Talent Acquisition representative. #J-18808-Ljbffr