QA Batch Record Reviewer

United Pharma; Texas; On-site; USD 85,000 - 115,000; Full time

Job summary

United Pharma is seeking experienced QA and Manufacturing Operations professionals to support GMP batch record review and production-floor activities. Approximately 75% of the assignment will be spent fully gowned on the production floor, performing real-time documentation reviews alongside manufacturing operations.

Responsibilities include real-time and completed batch record reviews for GMP compliance, discrepancy resolution with QA and Manufacturing, and support for room release and logbook

Qualifications

• Hands-on experience reviewing executed GMP manufacturing batch records is required.
• Pharmaceutical or biopharmaceutical manufacturing experience.
• Working knowledge of GMP documentation and aseptic processing or sterile fill-finish operations.
• Willingness to work approximately 75% of the time fully gowned on the production floor.
• Strong attention to detail, documentation, communication, and problem-solving skills.

Responsibilities

• Perform real-time and completed batch record reviews to ensure accuracy, completeness, and GMP compliance.
• Identify documentation discrepancies and coordinate timely resolution with QA and Manufacturing teams.
• Support production-floor activities, room release, logbook reviews, and batch documentation reconciliation.
• Verify scanned batch records and Component History Files against original documents.
• Assist with deviation investigation writing and technical narratives, depending on experience and assignment.
• Support material-consumption transactions in SAP when applicable and authorized.
• Maintain accurate documentation and communicate outstanding issues across cross-functional teams.

Skills

GMP batch records review

QA in pharma

Manufacturing operations

Aseptic processing

Documentation accuracy

Deviations investigation

Tools

MasterControl

SAP

Job description

United Pharma is seeking experienced QA and Manufacturing Operations professionals to support GMP batch record review and production-floor activities in a pharmaceutical or biopharmaceutical manufacturing environment. Approximately 75% of the assignment will be spent fully gowned on the production floor, performing real-time documentation reviews alongside manufacturing operations.

Key Responsibilities:

• Perform real-time and completed batch record reviews to ensure accuracy, completeness, and GMP compliance.
• Identify documentation discrepancies and coordinate timely resolution with QA and Manufacturing teams.
• Support production-floor activities, room release, logbook reviews, and batch documentation reconciliation.
• Verify scanned batch records and Component History Files against original documents.
• Assist with deviation investigation writing and technical narratives, depending on experience and assignment.
• Support material-consumption transactions in SAP when applicable and authorized.
• Maintain accurate documentation and communicate outstanding issues across cross-functional teams.

Skills & Qualifications:

• Hands-on experience reviewing executed GMP manufacturing batch records is required.
• Pharmaceutical or biopharmaceutical manufacturing experience.
• Working knowledge of GMP documentation and aseptic processing or sterile fill-finish operations.
• Willingness to work approximately 75% of the time fully gowned on the production floor.
• Strong attention to detail, documentation, communication, and problem-solving skills.

Preferred:

QA floor oversight, sterile manufacturing or biologics experience, deviation investigation writing, MasterControl, SAP, room release, and logbook review.