Batch Record Reviewer - 177301 - 177684

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Sick leave as required by law

Job summary

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

We are seeking multiple hires and moving quickly for qualified candidates with pharmaceutical manufacturing experience. Schedule is Monday–Friday, minimum 40 hours per week, with overtime opportunities at the start.

Qualifications

• Minimum 1 year of batch record review experience in a pharmaceutical manufacturing environment.
• 3-5+ years of batch record review experience strongly preferred.
• Biologics manufacturing experience is highly preferred.
• Familiarity with Quality Management Systems (QMS) and electronic quality systems.
• Experience using ERP and manufacturing systems such as SAP, Blue Mountain, or similar platforms.
• 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 discrepancies and support record approval.
• Review deviations, exceptions, investigations, and GMP documentation for regulatory compliance.
• 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 in both commercial and clinical environments.

Skills

Batch record review

Attention to detail

Quality system experience

Education

Bachelor's degree preferred

Tools

SAP

Blue Mountain

ERP systems

Job description

Piper Companies is seeking Batch Record Reviewers to support a leading biopharmaceutical manufacturing organization. This opportunity is a 6-month contract focused on reviewing GMP batch records, supporting manufacturing and quality operations, and helping reduce a significant documentation backlog. We are seeking multiple hires and are looking to move quickly for qualified candidates with pharmaceutical manufacturing experience.

Responsibilities for the Batch Record Reviewer:

• Review batch production records for accuracy, completeness, and compliance with GMP requirements.
• Partner closely with Manufacturing, Quality Assurance, 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.

Qualifications for the Batch Record Reviewer:

• Minimum of 1 year of batch record review experience in a pharmaceutical manufacturing environment required.
• 3-5+ years of batch record review experience strongly preferred.
• Experience supporting biologics manufacturing is highly preferred.
• Familiarity with Quality Management Systems (QMS) and electronic quality systems.
• Experience using ERP and manufacturing systems such as SAP, Blue Mountain, or similar platforms.
• Experience reviewing deviations, exceptions, investigations, or GMP documentation preferred.
• Bachelor's degree preferred but not required.
• Strong attention to detail and ability to navigate multiple quality and manufacturing systems

Compensation of the Batch Record Reviewer:

• $30-$37/hr
• Overtime opportunities expected, particularly at the beginning of the engagement.
• Contract Length: 6 Months.
• Comprehensive Benefits: Medical, Dental, Vision, sick leave if required by law

Additional Details:

• Schedule: Monday-Friday, minimum 40 hours per week.
• Flexible working hours.
• Opportunity to work closely with a large Manufacturing organization (175+ employees) and Quality team (50+ employees).
• Fast, streamlined interview process consisting of a 30-minute interview with Manufacturing and Quality leadership.
• Target Start Date: ASAP.

Keywords: Batch Record Reviewer, Batch Record Review, GMP, Pharmaceutical Manufacturing, Biologics, Quality Assurance, QA, Manufacturing Review, Quality Review, QMS, Quality Management System, SAP, Blue Mountain, ERP, Deviations, Exceptions, GMP Documentation, Batch Release, Biopharmaceutical Manufacturing, Commercial Manufacturing, Clinical Manufacturing, Quality Systems, Regulatory Compliance.

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