Batch Record Reviewer

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

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

Keywords:

Batch Record Review, Batch Records, GMP, cGMP, Biologics, Biotechnology, Pharmaceutical Manufacturing, Quality Assurance, QA Review, Quality Systems, QMS, ERP, SAP, Blue Mountain, Documentation Review, Manufacturing Operations, Clinical Manufacturing, Commercial Manufacturing, Deviation Management, Exception Management, Regulatory Compliance, SOPs, CAPA, FDA, Data Integrity, Production Records, Electronic Quality Systems, Quality Control, Batch Release, Investigations, Audit Readiness, Validation, Quality Documentation, Manufacturing Support, Life Sciences, Change Control, Durham NC, Onsite Contract, Biopharma, Process Documentation, Quality Review.