Batch Record Specialist

Key Responsibilities

• 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.
• Affirm batch review activities are completed within production timelines while maintaining quality standards.
• Assist with continuous improvement initiatives related to documentation practices and operational compliance.

Required Qualifications

• 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.