QA Batch Release Sr. Associate

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. 

What You Will Achieve

In this role, you will:

• 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 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.

Here Is What You Need (Minimum Requirements)

• 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

Bonus Points If You Have (Preferred Requirements)

• 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

  
Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control