GMP Batch Review Specialist

Operations Batch Review Specialist

Location: Fishers, Indiana (Onsite)
Industry: Pharmaceutical / Biotech Manufacturing
Employment Type: Contract

We are seeking an experienced Operations Batch Review Specialist to support pharmaceutical manufacturing operations in Fishers, Indiana. The ideal candidate will be responsible for reviewing batch documentation following manufacturing execution to ensure compliance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and regulatory requirements.

This role works closely with Manufacturing, Quality Assurance, and Quality Systems teams to ensure accurate documentation, support deviation investigations, implement CAPA actions, and facilitate timely batch release activities. Candidates with experience in sterile or parenteral manufacturing environments are strongly preferred.

• Review executed batch records for completeness, accuracy, and compliance with cGMP requirements.
• Perform detailed batch record review for parenteral manufacturing operations including Formulation, Filling, Inspection, and Packaging.
• Identify documentation discrepancies, deviations, and compliance concerns.
• Collaborate with Manufacturing and Quality teams to resolve documentation issues.
• Support deviation investigations, root cause analysis, and CAPA activities.
• Provide coaching and guidance to manufacturing operators regarding documentation best practices and GMP compliance.
• Review and analyze data from systems including eDMS, SCADA, BMS, CMMS, and LIMS.
• Assist with the creation, revision, and review of SOPs and work instructions.
• Support batch disposition and release readiness activities.
• Ensure documentation review timelines are met to avoid manufacturing and release delays.
• Maintain inspection readiness and support regulatory audits as needed.

• Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Chemistry, Engineering, or a related discipline.
• 3+ years of experience in pharmaceutical or biotechnology manufacturing.
• Experience performing Batch Record Review in a GMP‑regulated environment.
• Strong understanding of:
  • cGMP
  • Good Documentation Practices (GDP)
  • SOP compliance
  • Batch Release processes
  • Deviation Management
  • CAPA systems
• Experience supporting sterile, aseptic, or parenteral manufacturing operations.
• Strong attention to detail and documentation review skills.
• Excellent communication and cross‑functional collaboration abilities.

• Experience in biologics, vaccines, sterile injectables, or parenteral manufacturing.
• Familiarity with quality and manufacturing systems such as eDMS, LIMS, SCADA, BMS, and CMMS.
• Experience supporting FDA, EMA, or other regulatory inspections.
• Knowledge of quality systems, investigations, and compliance processes.

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