GMP Batch Records Specialist - Document Control

NCBioImpact; Morrisville (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Alcami is seeking an Associate Manufacturing Specialist to drive accurate batch documentation in a fast-paced aseptic manufacturing setting in Morrisville, NC. The role ensures GDP compliance and supports batch release with timely review of formulation and filling records.

Responsibilities include batch record handling, quality documentation, and training of operators to reinforce right-first-time manufacturing. The position is 100% on-site with a standard first shift.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field preferred; equivalent experience considered.
• 1–3+ years in GDP environment, pharmaceutical, biotech, or aseptic manufacturing operations preferred.

Responsibilities

• Batch Record Handling & Review: receive, organize, and manage batch records and documentation.
• Review batch records for accuracy, completeness, and compliance with cGMP and GDP.
• Identify, document, and resolve discrepancies, errors, and missing information.
• Ensure timely completion of record reviews to meet batch release timelines.
• Provide feedback and training to manufacturing technicians on documentation practices.
• Support internal and external audits by ensuring documentation accuracy and availability.
• Cross-Functional Support: collaborate with Manufacturing, QA, and Supply Chain to align on documentation needs.

Skills

GDP environment experience

Batch record review

Attention to detail

Verbal & written communication

Organization

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Engineering, or related field

Tools

MS Office

Job description

Alcami is seeking an Associate Manufacturing Specialist to drive accurate batch documentation in a fast-paced aseptic manufacturing setting in Morrisville, NC. The role ensures GDP compliance and supports batch release with timely review of formulation and filling records.

Responsibilities include batch record handling, quality documentation, and training of operators to reinforce right-first-time manufacturing. The position is 100% on-site with a standard first shift.