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Batch Record Reviewer Jobs in Raleigh, NC (NOW HIRING)

Vulcan Elements

Process Engineer - Pilot Ops

Durham, NC · On-site

Lead MES implementation at the pilot plant, including recipe management, electronic batch records ... Support internal audits and customer/partner quality reviews with organized, traceable production ...

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Batch Record Reviewer information

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How much do batch record reviewer jobs pay per hour?

As of Aug 22, 2026, the average hourly pay for batch record reviewer in Raleigh, NC is $19.77, according to ZipRecruiter salary data. Most workers in this role earn between $16.83 and $20.58 per hour, depending on experience, location, and employer.

What is a batch record reviewer?

A Batch Record Reviewer is responsible for reviewing manufacturing and production records to ensure compliance with regulatory standards and internal quality procedures. They verify that all documentation is complete, accurate, and meets Good Manufacturing Practices (GMP) requirements. Their role helps maintain product quality and ensures that any discrepancies or deviations are identified and addressed before product release. Batch Record Reviewers typically work in industries such as pharmaceuticals, biotechnology, and food manufacturing.

What does a batch record reviewer do?

A typical day for a Batch Record Reviewer involves meticulously examining batch records, manufacturing documentation, and supporting data to ensure compliance with regulatory and company standards. Reviewers frequently interact with production staff, quality assurance teams, and sometimes laboratory personnel to clarify discrepancies or gather additional information. Attention to evolving priorities and deadlines is common, especially when batches are ready for product release. This role offers valuable exposure to multiple departments and can serve as an excellent pathway to higher-level quality or regulatory positions within the company.

What skills and qualifications are needed to be a batch record reviewer?

To thrive as a Batch Record Reviewer, you need a keen attention to detail, strong analytical skills, and a solid understanding of Good Manufacturing Practices (GMP), often supported by a degree in life sciences or related fields. Familiarity with electronic documentation systems, quality management software, and sometimes certifications like Six Sigma or GMP training is highly valued. Excellent organization, communication, and problem-solving abilities are important soft skills for ensuring thorough and compliant record review. These competencies are crucial for maintaining product quality, regulatory compliance, and operational efficiency in pharmaceutical or biotech manufacturing environments.

What are popular job titles related to Batch Record Reviewer jobs in Raleigh, NC?

For Batch Record Reviewer jobs in Raleigh, NC, the most frequently searched job titles are:

What cities near Raleigh, NC are hiring for Batch Record Reviewer jobs?

Cities near Raleigh, NC with the most Batch Record Reviewer job openings:

Batch Record Reviewer jobs near you
Infographic showing various Batch Record Reviewer job openings in Raleigh, NC as of August 2026, with employment types broken down into 2% As Needed, 82% Full Time, 13% Part Time, and 3% Contract. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $41,123 per year, or $19.8 per hour.

6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2

Verista, Inc.

Durham, NC • On-site

Full-time

Re-posted 17 days ago

Job description

Position Summary

The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities, and PAT systems. This role is responsible for all computerized system validation (CSV) and data integrity (DI) activities, working under the direction of the Validation Lead and alongside the CQV team.

General CSV Skills

  • Familiarity with global standards for computerized systems and data integrity.
  • Ability to classify systems as "simple" or "complex" using riskbased criteria to rightsize validation effort.
  • Experience authoring CSV deliverables: URS/FDS/DDS review, risk assessments, test protocols (IQ/OQ), and summary reports.
  • Supplier assessment execution for OEMprovided computerized systems.
  • Data integrity assessment using ALCOA+ principles, including audit trail, user roles, time sync (NTP), backup/restore, and archival.

ProjectSpecific CSV Responsibilities

CSV Deliverables

  • Author Data Integrity Assessments for each Direct Impact computerized system, defining roles/privileges, and confirming electronic records handling.
  • Assess and document how PAT result data integrates with the paperbased manufacturing batch record (MBR) interface, ensuring data integrity at the point of data transfer.
  • Perform supplier assessments for major OEM systems and PAT instruments.
  • Author configuration specifications for computerized systems where client templates are available or where vendor documentation is insufficient.
  • Write CSV sections within IQ/OQ protocols - access control, audit trail verification, time sync (NTP), backup/restore, and data flow tests.
  • Develop data flow diagrams for critical integrations:
  • Execute IQ/OQ CSV test scripts, including; User role and access control, Audit trail review, Time synchronization, Backup and restore, and Data flow and accuracy 
  • PAT integration testing
  • Document any deviations discovered during CSV testing, perform impact assessment, and track CAPAs to closure.

Required Qualifications

  • Bachelor's degree in engineering, computer science, or related field.
  • Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments.
  • Proven experience with equipmentlevel PLC/HMI validation (OEM systems) and historian connectivity.
  • Handson experience with PAT instrument integration (e.g., NIR, moisture analyzers) is a strong plus.
  • Must be local in or around RTP, must be able to work on site 100%.

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