QA Specialist III

In this role, you will:

• Provide guidance, lead/co-lead projects for digital solutions
• Routinely provide updates to the team and management on project milestones .
• Independently support complex investigations in cross-functional work areas, providing sound quality assurance judgment to ensure product quality as needed.
• Ability to work in a fast-paced environment and be able and willing to juggle priorities as required.
• Reviews and approves electronic record, protocols and reports. Also authors, reviews and approves SOPs as appropriate (as required for support when necessary).
• 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 the input and background knowledge needed to complete assignments.
• Anticipate issues and provide recommendations for path forward to appropriate management attention immediately.
• Review and approval of change controls as needed for appropriateness, completeness and alignment with quality, validation and regulatory expectations
• Exercises judgment in resolving complex quality issues.
• Plans and executes work independently and consults with supervisor as needed, providing a recommendation for a solution.
• Incumbent knows and applies 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 applies 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

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, 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.  Therefore, 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 made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.