Qa Specialist III

Pfizer Pfizer · Pharma · MA

This role is a Quality Assurance Specialist at Pfizer, focused on ensuring drug batch compliance with specifications, managing change control, investigating deviations, and maintaining regulatory compliance with GxP standards. While the role mentions using AI tools like ChatGPT for productivity, its core function is not AI/ML development.

What you'd actually do

  1. Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
  2. Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
  3. Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
  4. Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
  5. 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.

Skills

Required

  • 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

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

What the JD emphasized

  • cGMP
  • GxP
  • Good Manufacturing Practices