GMP Batch Records Specialist (Onsite)

Piper Companies; North Carolina; On-site; USD 41,000 - 62,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401K

Sick leave as required by law

Job summary

Piper Companies in Durham, NC is seeking a detail‑oriented Batch Record Reviewer to ensure GMP compliance and accurate documentation across manufacturing operations. This onsite role focuses on QA collaboration and precise data review.

You will review production records, investigate discrepancies with QA leadership, and ensure readiness for release using electronic quality systems. The 6‑month contract offers a Monday–Friday schedule, competitive hourly pay, and comprehensive benefits.

Qualifications

• Minimum 1 year of batch record review in a regulated environment; 3–5+ years preferred.
• Hands-on experience with QMS and electronic quality platforms; multiple systems desirable.
• Experience using ERP platforms such as SAP or Blue Mountain, or equivalent.
• Knowledge of GMP documentation practices, deviation management, and quality reviews.
• Degree preferred but not required; strong industry experience encouraged.

Responsibilities

• Review production batch records for GMP compliance and documentation standards.
• Collaborate with manufacturing personnel, supervisors, and QA leadership to resolve discrepancies.
• Evaluate records and quality events for completeness prior to release.
• Utilize electronic systems to document reviews, track findings, and support workflow.
• Contribute to backlog reduction while maintaining regulatory compliance across operations.

Skills

Batch record review

GMP knowledge

Quality Assurance

QA review processes

Data integrity

Regulatory awareness

Education

Degree preferred

Tools

SAP

Blue Mountain

ERP systems

Job description

Piper Companies in Durham, NC is seeking a detail‑oriented Batch Record Reviewer to ensure GMP compliance and accurate documentation across manufacturing operations. This onsite role focuses on QA collaboration and precise data review.

You will review production records, investigate discrepancies with QA leadership, and ensure readiness for release using electronic quality systems. The 6‑month contract offers a Monday–Friday schedule, competitive hourly pay, and comprehensive benefits.