Senior Quality Assurance Specialist

About the Role Pfizer Global Supply is seeking a Senior Quality Assurance Specialist to ensure compliance with regulatory and Pfizer quality standards within manufacturing operations. This role evaluates drug batches, leads investigations, and supports cGMP compliance to ensure safe and effective products reach patients. What You'll Do

• Evaluate and review 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 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. What We're Looking For
• Bachelor of Sciences/Pharmacy with 8+ years of experience or Masters degree with 6+ years of experience with relevant experience in Manufacturing upstream/downstream operations.
• 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. Nice to Have
• 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. Compensation & Benefits
• Benefits: Competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.