QA Specialist III

What You Will Achieve

In this role, you will provide guidance and lead/co-lead projects for digital solutions, routinely update the team and management on project milestones, and independently support complex investigations in cross-functional work areas with sound quality assurance judgment.

• Independently support complex investigations in cross-functional work areas, providing sound quality assurance judgment to ensure product quality as needed.
• Work in a fast-paced environment and juggle priorities as required.
• Review and approve electronic records, protocols and reports; author, review and approve SOPs as appropriate.
• Independently provide Quality Review and oversight of site documentation to ensure compliance with global regulatory agencies and Pfizer quality standards.
• Collaborate/independently engage with a wide range of co-workers, customers and management within PGS (external sites as necessary) to gather input and background knowledge needed to complete assignments.
• Anticipate issues and provide recommendations for path forward to appropriate management attention immediately.
• Review and approve change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations.
• Exercise judgment in resolving complex quality issues; plan and execute work independently and consult with supervisor as needed, providing a recommendation for a solution.
• Know and apply technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
• Lead and drive continuous improvement activities.
• Proactively and independently apply sound technical judgment to resolve quality issues.
• Drive effective management of quality issues and Corrective Action Plan (CAPAs) and make decisions that may involve complex quality and technical issues.

Here Is What You Need (Minimum Requirements)

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BA/BS with 2+ years of experience.
• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards.
• Experience in a GMP manufacturing role or a GMP Quality Assurance role.
• 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.