QA Specialist III

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

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

What You Will Achieve 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

PHYSICAL/MENTAL REQUIREMENTS n/a NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS n/a

Other Job Details: Work Location Assignment: Hybrid Relocation Assistance Available: NO Last date to apply: 11/13/2026 The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. Sunshine Act 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.

EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.