Quality Specialist - Batch Record Review

Quality Specialist II
- Batch Record Review

Raleigh, NC

Pay: $22.00 - $24.00 per hour

26-07733

Job Summary

The Quality Specialist II
- Batch Record Review is responsible for reviewing manufacturing and packaging batch records to ensure compliance with current Good Manufacturing Practices (cGMP), internal quality standards, and regulatory requirements. This role supports product release activities by verifying production documentation, identifying discrepancies, and collaborating with Manufacturing and Quality teams to ensure accurate and compliant records. The position also supports quality systems, facility inspections, material status verification, and continuous improvement initiatives within a regulated manufacturing environment.

• Review manufacturing and packaging batch records for completeness, accuracy, and compliance with cGMP requirements, SOPs, and internal quality standards.
• Verify that critical manufacturing steps, in-process inspections, reconciliations, and production documentation have been completed accurately.
• Identify documentation discrepancies, omissions, or errors and coordinate timely resolution with Manufacturing and Quality teams.
• Support product disposition activities by assessing batch documentation and escalating quality concerns as needed.
• Retrieve production batch records for review and return completed documentation following approval.
• Scan, organize, and maintain batch records in accordance with documentation and data integrity requirements.
• Assist with investigations involving deviations, nonconformances, and Corrective and Preventive Actions (CAPAs) related to production documentation.
• Verify identification and status labeling of raw materials, intermediates, and in-process materials.
• Conduct inspections of manufacturing equipment, production areas, and materials to ensure compliance with quality standards.
• Support inventory status control activities, including quarantine, approved, and rejected materials.
• Assist with facility compliance activities, including pest control program support and vendor documentation review.
• Provide guidance to production personnel on proper batch record documentation practices.
• Participate in continuous improvement initiatives to enhance quality processes and regulatory compliance.
• Maintain organized quality documentation and perform additional Quality Assurance responsibilities as assigned.

• Minimum of 1-3 years of Quality Assurance experience in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment.
• Associate degree in a scientific, technical, or related discipline required.
• Experience performing end-of-process Quality Assurance activities;
  Quality Control experience alone is not sufficient.
• Experience reviewing and scanning manufacturing batch records.
• Working knowledge of current Good Manufacturing Practices (cGMP).
• Proficiency with Microsoft Word and Excel.
• Strong attention to detail and documentation accuracy.
• Excellent organizational, verbal, and written communication skills.
• Ability to manage multiple priorities and meet deadlines.

• Associate degree in a scientific, technical, or related discipline required.

• 1-3 years of experience in Quality Assurance within a regulated manufacturing environment.
• Previous batch record review experience in pharmaceutical manufacturing preferred.
• Experience supporting deviations, CAPAs, investigations, or quality systems preferred.
• Familiarity with FDA-regulated manufacturing environments and data integrity principles preferred.

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