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GMP Batch Record Reviewer | MBR | QA Documentation | Pharma / Biotech | cGMP | eQMS

Fishers, IN, US • Posted 1 day ago • Updated 9 hours ago

Contract W2

No Travel Required

On-site

Depends on Experience

Fitment

Dice Job Match Score™

⭐ Evaluating experience...

Job Details

Skills

Master Batch
Good Manufacturing Practice
Manufacturing
Regulatory Compliance
Quality Management
CDMO
eQMS

Summary

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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10360765
Position Id: 8939789
Posted 1 day ago

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