GMP Batch Record Reviewer | MBR | QA Documentation | Pharma / Biotech | cGMP | eQMS
Fishers, Delaware, United States of America
Contract
1 week ago
About this role
Job Summary
We are hiring a GMP Batch Record Reviewer / MBR Specialist with strong experience in pharmaceutical or biotech manufacturing environments. This role focuses on reviewing, authoring, and maintaining batch records (MBR/BPR) while ensuring full compliance with cGMP, FDA, and data integrity standards.
Ideal candidates will have hands-on experience with batch record review, GMP documentation, and quality systems (eQMS).
Core Responsibilities
- Review Master Batch Records (MBR) and Batch Production Records (BPR) for accuracy, completeness, and compliance
- Ensure alignment with cGMP, FDA, ICH guidelines, and internal procedures
- Author, revise, and maintain controlled GMP documents
- Support change control, CAPA, and deviation-related documentation updates
- Collaborate with Manufacturing, QA, QC, and Validation teams
- Maintain document lifecycle management (versioning, issuance, archival)
- Ensure audit readiness for FDA inspections and regulatory audits
- Provide guidance on GMP documentation best practices
- Work within electronic Quality Management Systems (eQMS)
Required Skills
- GMP / cGMP compliance
- Batch Record Review (MBR / BPR)
- QA Documentation / Technical Writing
- FDA regulations / ICH guidelines
- Data Integrity (ALCOA principles)
- Change Control / CAPA / Deviations
- eQMS systems (TrackWise, Veeva, MasterControl or similar)
- Pharmaceutical / Biotech Manufacturing
Preferred Skills
- Aseptic / Sterile manufacturing
- Biologics or drug product experience
- Process Validation / Equipment Qualification
- CDMO environment experience
- Audit / Inspection support
Qualifications
- Bachelor’s degree or relevent experience in Life Sciences, Engineering, or related field
- 3–5+ years of experience in pharma, biotech, or regulated manufacturing
- Strong attention to detail and documentation accuracy
Work Details
- Location: Indiana (Onsite role)
- Industry: Pharmaceutical / Biotech Manufacturing
- Employment Type: Contract