Batch Record Specialist

Batch Record Specialist

Location:

Indiana (Onsite) | Duration: 6-Month Contract

We are seeking an experienced Operations Batch Review Specialist to support manufacturing operations within a GMP-regulated pharmaceutical environment. This role will be responsible for reviewing executed batch records and manufacturing documentation to ensure compliance with cGMP requirements, regulatory standards, and internal procedures.

The ideal candidate will possess strong batch record review experience, a solid understanding of parenteral manufacturing processes, and the ability to collaborate with Operations, Quality, and Manufacturing teams to drive documentation accuracy, deviation resolution, and continuous improvement initiatives.

• Review completed batch records and manufacturing documentation for accuracy, completeness, and compliance with cGMP requirements.
• Verify manufacturing activities were performed according to approved procedures, specifications, and regulatory standards.
• Identify documentation errors, discrepancies, and potential deviations, ensuring appropriate corrections are completed.
• Partner with Manufacturing Operations to provide coaching and guidance on good documentation practices.
• Support deviation investigations, root cause analysis, and CAPA implementation activities.
• Collaborate with Quality Systems, Production, and Technical Operations teams to resolve documentation and compliance issues.
• Ensure batch review activities are completed within production timelines while maintaining quality standards.
• Assist with continuous improvement initiatives related to documentation practices and operational compliance.
• Build strong working relationships with process owners, supervisors, and subject matter experts to drive quality-focused outcomes.

• Experience performing full batch record review in GMP-regulated pharmaceutical manufacturing environments.
• Strong knowledge of parenteral manufacturing operations, including:
  • Formulation
  • Filling
  • Inspection
  • Packaging
• Experience identifying and documenting deviations, investigations, and corrective actions.
• Ability to coach operators and manufacturing personnel on documentation requirements and compliance expectations.
• Strong understanding of:
  • cGMP Regulations
  • Process Control
  • Quality Systems
  • Sampling Plans
  • Statistical Techniques
  • Process Capability
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.