QA Associate

Pfizer; United States; On-site; USD 69,000 - 114,000; Full time

Job summary

Pfizer is seeking a QA professional to contribute to complex projects, manage timelines, and help maintain the highest quality standards. The role focuses on batch record review for Drug Substance and Drug Product, SOP validation, and supporting inspection readiness across the site.

The candidate should have a strong background in GxP, excellent communication skills, and the ability to work within cross-functional teams while proactively addressing compliance issues.

Qualifications

• Experience in pharmaceutical industry and GxP regulations (cGMP)
• Ability to work within cross-functional teams
• Strong written and oral communication skills
• Proactive approach and critical thinking
• Experience with digital applications / AI tools (Co-Pilot, eBR, etc)

Responsibilities

• Contribute to complex projects and manage own time to meet targets.
• Review and approve batch records for Drug substance and Drug Product.
• Review SOP revisions and validation documentation.
• Ensure documents for batch release are complete and accurate.
• Make quality decisions with guidance from management.
• Support site readiness for inspections and participate in audits.
• Identify issues beyond own scope and escalate as needed.
• Assist manufacturing staff in detecting compliance errors in real time.

Skills

GxP familiarity

Audits & inspections

Team collaboration

Communication (written & verbal)

Problem solving

Digital applications / AI tools

Education

Bachelor's degree

Associate degree

High school diploma

Job description

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.

What You Will Achieve

• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Review and approve various Good Manufacturing Practices {also cGMP} records (primarily batch records for Drug substance and Drug Product) and investigations.
• Review/Approve Standard Operating Procedures (SOPs) revisions and Validation Documentation (Periodic Reviews)
• Ensure that all documents for batch release are reviewed for completeness and accuracy.
• Make Quality decision to resolve moderately complex issues with assistance from management/Sr. Staff
• Seek out and assess internal and external compliance with applicable regulations.
• Support the site relative to a constant state of inspection readiness. Participate in audits relative to this role as needed.
• Recognize when an issue is beyond your sphere of influence and elevate immediately.
• Participate in Limited Duration Teams, Continuous Improvement (CI) projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
• Assist and support the manufacturing staff in detecting and solving compliance errors in real time during manufacturing operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.
• May participate in the release of raw materials, as needed.
• Procedural Administration/Active Library Support as needed

Here Is What You Need (Minimum Requirements)

• Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience.
• Experience in pharmaceutical industry
• Sound knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.
• Ability to work in a team environment within own team and interdepartmental teams.
• Excellent communication and interpersonal skills
• Proactive approach and strong critical thinking skills.
• Effective written and oral communication skills
• Experience with Digital Applications /Solutions (Co-Pilot, AI applications, eBR, etc)

Bonus Points If You Have (Preferred Requirements)

• Experience at a manufacturing site
• Experience of writing and managing deviations
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management is preferred

PHYSICAL/MENTAL REQUIREMENTS

• Mental agility to handle a large quantity and broad scope of different types of quality assurance work.
• Ability to work independently, problem solve and make recommendations for solutions.
• Role is primarily office-sitting. Position requires walking, sitting, standing, and carrying batch records from one location to another as Andover site is a campus setting.
• Able to lead and/or participate in person or Microsoft Teams meetings.

Other Job Details:

Last day to Apply: August 28, 2026

Work Location Assignment: On Premise

The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% 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.

Pfizer reports