GMP Batch Records Specialist

Piper Companies; Durham (NC); On-site; USD 41,000 - 51,000; Full time

Job summary

Piper Companies is seeking Batch Record Reviewers to support a leading biopharmaceutical manufacturing organization on a 6-month contract. The role focuses on reviewing GMP batch records, supporting manufacturing and quality operations, and helping reduce a significant documentation backlog.

You will work with Manufacturing and QA teams, review deviations and GMP documentation, and use SAP or similar ERP systems.

Qualifications

• 1 year minimum batch record review experience in a pharmaceutical manufacturing environment.
• 3-5+ years batch record review experience strongly preferred.
• Experience supporting biologics manufacturing is highly preferred.
• Familiarity with QMS and electronic quality systems.
• Experience using ERP/manufacturing systems such as SAP, Blue Mountain.
• Bachelor's degree preferred but not required.
• Strong attention to detail and ability to navigate multiple quality and manufacturing systems.

Responsibilities

• Review batch production records for accuracy, completeness, and GMP compliance.
• Partner with Manufacturing, QA, supervisors, and quality leaders to resolve documentation discrepancies and support record approval.
• Review deviations, exceptions, and supporting quality documentation to ensure compliance with site procedures and regulatory standards.
• Utilize quality and manufacturing systems to support batch record review activities and documentation workflows.
• Assist with backlog reduction efforts while maintaining attention to detail and quality standards.
• Collaborate cross-functionally with Manufacturing and QA teams within both commercial and clinical manufacturing environments.

Skills

Batch record review

Pharmaceutical manufacturing

Quality Assurance

GMP compliance

Attention to detail

Cross-functional teamwork

Education

Bachelor's degree

Tools

SAP

Blue Mountain

Job description

Piper Companies is seeking Batch Record Reviewers to support a leading biopharmaceutical manufacturing organization on a 6-month contract. The role focuses on reviewing GMP batch records, supporting manufacturing and quality operations, and helping reduce a significant documentation backlog.

You will work with Manufacturing and QA teams, review deviations and GMP documentation, and use SAP or similar ERP systems.