Batch Review Specialist
INCOG BioPharma ServicesFishers, Indiana, United States
Posted May 27, 2026
Full Time
About the Company
INCOG BioPharma is a world-class CDMO for parenteral injectable drugs, with a culture focused on building long-term value for customers, technical excellence, and a collaborative approach.
Job Description
The Operations Batch Review Specialist is responsible for reviewing batch documentation post execution to ensure that all work completed was carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) while maintaining the highest possible quality standards.
Requirements
- Full batch documentation review of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
- Identify correction, deviations and escalate found issues to Operations and Quality Supervisors.
- Provide training and feedback to Operators and Supervisors to improve on-the-floor Batch Record reviews during execution.