QA Specialist III

Pfizer Inc

United States

Hybrid

USD 83,000 - 138,000

Full time

3 days ago
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Benefits offered by this job

Bonus program
401(k) plan
Paid vacation

Job summary

Pfizer Inc is seeking a Quality Assurance professional to lead and co-lead digital solution projects while providing QA oversight across cross-functional teams. You will review changes, approve change controls, and ensure documentation aligns with GMP and regulatory expectations.

The role requires strong critical thinking, problem solving, and collaboration within a hybrid work environment in the United States.

Qualifications

  • Knowledge of current Good Manufacturing Practices (GMP) and GxP regulations.
  • Experience in GMP manufacturing or GMP Quality Assurance roles.
  • Strong critical thinking and problem-solving abilities.
  • Ability to collaborate across interdepartmental teams.
  • Proactive approach to problem-solving and documentation.

Responsibilities

  • Lead and co-lead digital solution projects and provide updates to team and management.
  • Support complex investigations and provide QA judgments to ensure product quality.
  • Review and approve change controls for regulatory alignment.
  • Provide quality review of site documentation to ensure compliance.
  • Engage with cross-functional partners to gather input and drive solutions.
  • Drive continuous improvement and manage CAPAs as needed.

Skills

GxP regulations knowledge
Critical thinking
Problem solving
Team collaboration

Education

Bachelor's degree or equivalent in related field

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


  • 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


O ther 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 i

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