QA Specialist III

Pfizer • Andover, MA

1d • $82,700 - $137,900 • Hybrid

About The Position

Pfizer is seeking a QA Specialist III to support its quality culture and help ensure the delivery of safe and effective products. The role provides quality assurance judgment and oversight across complex investigations, site documentation, electronic records, protocols, reports, SOPs, and change controls. The specialist applies technical and quality concepts, regulatory requirements, and relevant SOPs, while exercising independent judgment to resolve complex quality issues and recommending solutions to management.

The position also contributes to digital solution projects and continuous improvement activities, and drives effective management of quality issues and corrective action plans (CAPAs). The role involves collaborating with colleagues, customers, management, and potentially external sites to gather information and complete assignments. The work location is hybrid. The position is eligible for Pfizer’s Global Performance Plan with a 10% bonus target. The annual base salary range is $82,700 to $137,900. Candidates must be authorized to work in the U.S.; visa sponsorship is not available.

Requirements

• High school diploma or equivalent and 8 or more years of experience, or an associate’s degree and 6 or more years of experience, or a BA/BS and 2 or more years of experience.
• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards.
• Experience in a GMP manufacturing or GMP Quality Assurance role.
• Strong critical-thinking skills.
• Ability to work effectively within the candidate’s team and with interdepartmental teams.
• Good working knowledge of Microsoft Excel and Word.
• Proactive approach to problem-solving.

Nice To Haves

• Experience with quality-administered systems.
• Strong organizational skills and attention to detail.
• Experience with regulatory compliance and documentation.
• Ability to mentor colleagues and review their work.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem-solving and productivity; curiosity about how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Provide guidance and lead or co-lead projects for digital solutions.
• Provide regular updates to the team and management on project milestones.
• Independently support complex investigations across cross-functional work areas, applying sound quality assurance judgment to help ensure product quality.
• Review and approve electronic records, protocols, and reports; author, review, and approve SOPs as appropriate and when needed.
• Provide independent quality review and oversight of site documentation to ensure compliance with global regulatory requirements and Pfizer quality standards.
• Collaborate with colleagues, customers, management, and external sites as needed to gather input and background information for assignments.
• Anticipate issues and promptly bring them to appropriate management attention with recommendations for a path forward.
• 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, consulting a supervisor as needed and recommending solutions.
• Apply technical and quality concepts, applicable FDA or other regulatory guidance, and relevant SOPs.
• Lead and drive continuous improvement activities.
• Proactively apply sound technical judgment to resolve quality issues.
• Drive effective management of quality issues and CAPAs, making decisions that may involve complex quality and technical issues.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility for Pfizer’s Global Performance Plan with a 10% bonus target.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED