Manufacturing Batch Review Specialist

The Operations Batch Review Specialist is responsible for reviewing batch documentation in accordance with regulatory requirements, Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs). They will provide feedback, improve documentation, and work closely with quality systems, operations, and engineering teams to ensure high quality and timely completion of manufacturing activities. This role emphasizes clear communication and the ability to influence positive outcomes.

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.
• Provide training and feedback to Operators and Supervisors.
• Support Quality Systems with batch impacting deviations to support on time batch release activities.
• Utilize various paper and automated systems (SCADA, CMMS, LIMS, etc.).
• Manage multiple projects in a fast-paced environment.

Benefits

• Equal Opportunity Employer
• Culture Focused
• Technical Excellence
• Collaborative Teamwork
• Process Ownership
• Proactive Approach