QO DP Tech III

About the role

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.

Responsibilities

• 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 conform to Pfizer policy and cGMP's.
• Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate 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.
• Serve as audit support SME as needed.
• Support IMEX initiatives within the team.
• Utilize appropriate systems to complete tasks (LRT, LIMs, SAP, PacOne, QTS, PDOCs, etc…).

Requirements

• 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

Qualifications

• 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

Skills

• Strong written and oral communication skills

Benefits

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.

Pay

The salary for this position ranges from $23.64 to $39.39 per hour.

Schedule

Flexible working hours (1st shift).

Location

Work Location Assignment: On Premise

Other Job Details

Last day to apply: September 3rd, 2026.