Batch Record Reviewer

Responsibilities

• Perform detailed reviews of production batch records to ensure compliance with GMP requirements, internal procedures, and documentation standards.
• Partner with manufacturing personnel, supervisors, and quality leadership to investigate and resolve documentation discrepancies or record exceptions.
• Evaluate production records, supporting documentation, and associated quality events for completeness and accuracy prior to release activities.
• Utilize electronic quality and business systems to document reviews, track findings, and support workflow efficiency.
• Contribute to backlog reduction initiatives while maintaining a high level of accuracy and regulatory compliance across manufacturing operations.

Qualifications

• Minimum of 1 year of batch record review experience within a pharmaceutical, biotechnology, biologics, or other regulated manufacturing environment; 3-5+ years preferred.
• Hands-on experience with Quality Management Systems (QMS) and electronic quality platforms; familiarity with multiple systems is highly desirable.
• Experience using ERP platforms such as SAP, Blue Mountain, or equivalent manufacturing and quality systems.
• Knowledge of GMP documentation practices, deviation management, exception tracking, and quality review processes.
• Degree preferred but not required; candidates with strong industry experience and proven batch record review expertise are encouraged to apply.

Compensation

• Salary Range: $30/hour - $45/hour
• Schedule: Monday - Friday, 8:00 AM - 5:00 PM with flexibility in working hours
• Location: Durham, NC
• Work Arrangement: 100% Onsite
• Contract Duration: 6 Months
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law, and 401K

Application Details

• Posting Date: 10/21/2026
• Apply By/Closing Date: Open Until Filled

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