Senior QA Specialist: Digital Quality & Compliance Lead

Pfizer Inc; Andover (MA); Hybrid; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) with Pfizer Matching

Comprehensive benefits package

Paid vacation and leave

Job summary

Pfizer is seeking a Quality Assurance professional to provide guidance and lead digital solutions projects within a GMP environment. You will review electronic records, SOPs, and change controls, and collaborate with cross-functional teams to ensure product quality and regulatory compliance.

You will independently support investigations, drive CAPAs, and contribute to continuous improvement while navigating a fast-paced setting and aligning with FDA/GxP standards in a hybrid work arrangement.

Qualifications

• High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years 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 or GMP Quality Assurance role.
• Strong critical thinking skills and proactive problem-solving approach.
• Ability to work effectively within own team and interdepartmental teams.

Responsibilities

• Provide guidance, lead/co-lead projects for digital solutions.
• Routinely provide updates to the team and management on project milestones.
• Independently support complex investigations with sound QA judgment.
• Review and approve electronic records, protocols and reports.
• Authors/reviews/approves SOPs as appropriate for support.
• Independently provide QA review/oversight of site documentation for regulatory compliance.
• Collaborate with a wide range of coworkers, customers and management.
• Anticipate issues and provide recommendations to management.
• Review and approve change controls for appropriateness and alignment with requirements.
• Drive continuous improvement and manage CAPAs.

Skills

Critical thinking

Project coordination

Cross-functional collaboration

Problem solving

Adaptability

Education

BA/BS degree

Associate’s degree

High school diploma

Tools

Microsoft Excel

Microsoft Word

Job description

Pfizer is seeking a Quality Assurance professional to provide guidance and lead digital solutions projects within a GMP environment. You will review electronic records, SOPs, and change controls, and collaborate with cross-functional teams to ensure product quality and regulatory compliance.

You will independently support investigations, drive CAPAs, and contribute to continuous improvement while navigating a fast-paced setting and aligning with FDA/GxP standards in a hybrid work arrangement.