QO DP Tech III

Pfizer; United States; On-site; USD 33,000 - 54,000; Full time

Job summary

Pfizer is seeking an experienced Quality Assurance Drug Product Batch Record Reviewer to join its Global Quality organization. You will evaluate clinical and commercial drug batches, verify documents match specifications, and approve change controls to ensure cGMP compliance.

In this on-site role, you will help drive continuous improvement, participate in risk assessments, and support inspections by regulatory bodies. Strong teamwork, attention to detail, and knowledge of GMP/cGMP are essential.

Qualifications

• High School Diploma and 4+ years of pharmaceutical experience.
• Experience in pharmaceutical industry and Quality administered systems.
• Sound knowledge of current Good Manufacturing Practices (GxP).
• Ability to work in a team environment with cross-functional teams.
• Effective written and oral communication skills.

Responsibilities

• Evaluate and review clinical and commercial drug batches.
• Verify that batch records and documents meet specifications.
• Approve change controls to ensure compliance with cGMP.
• Identify deviations from standards and drive corrective actions.
• Maintain readiness for regulatory inspections and customer audits.
• Support continuous improvement initiatives within QA Drug Product Batch Record Review.

Skills

4+ years experience

Team collaboration

Communication skills

Pharma industry knowledge

Education

High School Diploma

Tools

LRT

LIMS

SAP

PacOne

QTS

PDOCs

eQMS

Job description

Use Your Power for PurposeEvery 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

You will be a member of Pfizer's dedicated and highly effective Quality Assurance Drug Product Batch Record Review team. You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• 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.
• Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.
• Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
• Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalates issues with potential market or stability impact.
• Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
• Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.
• Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
• Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
• Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.
• Help to define appropriate action plans for improvement and follow-up and communicate action closures.
• Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.
• Maintain SOPs/OJTs/etc. for Manufacturing and Packaging records.
• Work with Operations to correct and reduce errors through effective communication and continuous improvement initiatives.
• Serve as audit support SME as needed.
• Drive continuous improvement initiatives to support the overall attainment goal.
• Support IMEX initiatives within the team.
• Utilize appropriate systems to complete tasks (LRT, LIMs, SAP, PacOne, QTS, PDOCs, etc...).

Here Is What You Need (Minimum Requirements)

• Applicant must have a High School Diploma and 4+ years of experience
• Experience in pharmaceutical industry
• Experience in Quality administered systems
• Sound knowledge of current Good Manufacturing Practices {part of GxP}
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills

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
• Experience with the following systems: eQMS, gLIMS, SAP, PDOCs, LRT, Batch Tracker

Physical/Mental Requirements

• Office position with time in the production environment.
• Consistently produces quality work.
• Must be able to work in a team environment within own team and interdepartmental teams.
• Must work under short timelines while maintaining quality work.
• Must have strong written and oral communication skills.

Non-Standard Work Schedule, Travel, or Environment Requirements

• Flexible working hours (1st shift).
• Work Location Assignment: On Premise

Other Job Details

Last day to apply: September 3rd, 2026.

The salary for this position ranges from $23.64 to $39.39 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. 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 40