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Quality Assurance Batch Record Review Jobs (NOW HIRING)

AbbVie

PR · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

The Specialist, Quality Assurance is responsible for QA batch record review and disposition ... The batch record review encompasses manufactured batch records, investigation of deviations ...

Abzena Inc.

QA Specialist

San Diego, CA · On-site

$90K - $125K/yr

The QA Operations Specialist will support the Abzena operations teams to drive continuous ... Be an SME of batch record review and disposition of buffers / media manufactured by Abzena.

Abzena

QA Specialist

San Diego, CA · On-site

$90K - $125K/yr

The QA Operations Specialist will support the Abzena operations teams to drive continuous ... Be an SME of batch record review and disposition of buffers / media manufactured by Abzena.

Abzena

QA Specialist

San Diego, CA · On-site

$90K - $125K/yr

The QA Operations Specialist will support the Abzena operations teams to drive continuous ... Be an SME of batch record review and disposition of buffers / media manufactured by Abzena.

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How much do quality assurance batch record review jobs pay per hour?

As of Aug 14, 2026, the average hourly pay for quality assurance batch record review in the United States is $29.29, according to ZipRecruiter salary data. Most workers in this role earn between $18.75 and $34.38 per hour, depending on experience, location, and employer.

What are some common challenges faced during quality assurance batch record review, and how can they be managed?

One common challenge in Quality Assurance Batch Record Review is identifying and resolving discrepancies or incomplete documentation within batch records, which can slow down release timelines. To manage this, QA professionals often work closely with production and laboratory teams to clarify issues and ensure thorough documentation. Another challenge is staying up-to-date with evolving regulatory requirements, which requires ongoing training and attention to detail. Effective communication, strong organizational skills, and a proactive approach to documentation can help overcome these hurdles and ensure compliance.

What are the key skills and qualifications needed to thrive as a quality assurance batch record review specialist, and why are they important?

To thrive as a Quality Assurance Batch Record Review specialist, you need a strong understanding of GMP regulations, pharmaceutical manufacturing processes, and a relevant science degree. Familiarity with electronic batch record systems, document management software, and regulatory compliance databases is typically required. Attention to detail, critical thinking, and effective communication are crucial soft skills for identifying discrepancies and ensuring compliance. These skills are vital to maintain product quality, meet regulatory standards, and prevent costly production errors.

What is quality assurance batch record review?

Quality Assurance Batch Record Review is a process in which QA professionals examine manufacturing batch records to ensure that all production and quality control steps have been completed according to regulatory standards and company procedures. This review helps to identify any discrepancies, deviations, or errors before products are released for distribution. By meticulously checking documentation, QA specialists help maintain product integrity, regulatory compliance, and patient safety. The role is essential in the pharmaceutical, biotech, and manufacturing industries.

What is the difference between Quality Assurance Batch Record Review vs Quality Control Inspector?

AspectQuality Assurance Batch Record ReviewQuality Control Inspector
Primary FocusReviewing and approving batch records for compliance and accuracyInspecting products and materials for quality and defects
ResponsibilitiesEnsuring batch documentation meets regulatory standardsPerforming physical inspections and testing of products
CredentialsTypically requires QA certifications, GMP knowledgeOften requires quality control or lab certifications
Work EnvironmentOffice-based review, documentation-focusedManufacturing floor, lab testing environment

While both roles ensure product quality, the Quality Assurance Batch Record Review focuses on document review and compliance, whereas the Quality Control Inspector conducts physical product inspections. Both are essential for maintaining quality standards in manufacturing industries.

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Quality Assurance Batch Record Review jobs near you
Infographic showing various Quality Assurance Batch Record Review job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 14% Part Time, 4% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $60,925 per year, or $29.3 per hour.

Quality Assurance - Batch Record Review Specialist with Security Clearance

Beacon Hill

Albany, NY • On-site

Other

Posted 2 days ago

New

Job description

The Quality Assurance Batch Record Reviewer is responsible for the complete, accurate, and compliant review of batch production records for sterile drug products manufactured in a 503B outsourcing facility. This role performs QA review of documentation, data integrity, verifies adherence to CGMP and aseptic processing requirements, and supports timely batch release. The Reviewer works closely with Manufacturing, Quality Control, and Compliance to maintain audit-ready documentation and uphold sterility assurance standards. Key Responsibilities Batch Record Review & Documentation Control * Perform detailed review of Batch Production Records (BPRs), ensuring completeness, accuracy, and compliance with CGMP and 503B requirements. * Verify all critical manufacturing steps, in-process checks, component usage, equipment logs, and operator entries. * Ensure reconciliation of materials, components, and labels. * Review associated documentation including EM results, equipment calibration, sterilization records, and deviation reports. Aseptic Processing Compliance * Confirm documentation supports aseptic technique, cleanroom behavior, and contamination control expectations. * Ensure all required pre- and post-processing checks (line clearance, equipment setup, environmental conditions) are properly documented. * Validate that manufacturing of batches meet acceptance criteria. Deviation, Investigation & Change Control Support * Identify documentation gaps, errors, or potential deviations during record review. * Initiate and support investigations related to batch discrepancies, EM excursions, or equipment issues. * Collaborate with QA and Operations to ensure corrective actions are documented and effective. Batch Release Support * Prepare batch record review summaries and release recommendations for QA management. * Ensure all required supporting documents are present, accurate, and audit-ready. * Maintain strict adherence to batch release timelines. Data Integrity & Compliance * Ensure all documentation meets ALCOA+ data integrity principles. * Maintain controlled forms, logs, and templates in accordance with document control procedures. * Support internal audits and FDA inspections by presenting documentation and responding to technical questions. Qualifications * Bachelor's degree in Life Sciences, Chemistry, Biology, Engineering, or related field. * 3-5 years of experience in aseptic pharmaceutical manufacturing, sterile injectable(s), 503B manufacturing. * Knowledge and understanding of CGMP, Annex 1, USP / / , and FDA 503B guidance. * Experience reviewing batch records, manufacturing documentation, or QA compliance records. * Excellent attention to detail and strong documentation discipline. * Ability to interpret manufacturing processes, equipment logs, and aseptic workflow requirements. Competencies * High accuracy and attention to detail. * Strong communication skills and ability to work cross-functionally. * Ability to identify documentation gaps and drive resolution. * Comfortable working in a fast-paced, highly regulated environment. * Commitment to sterility assurance and contamination control.

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