Associate Lead I - Biomanufacturing Compliance - Training

Catalent seeks an Associate Lead I for biomanufacturing training and compliance at its Madison biologics facility. The role involves designing and delivering training programs, tracking compliance metrics, and supporting operational excellence in a GMP manufacturing environment. Position requires 4+ years related experience or relevant degree.

Responsibilities

• Track and monitor training activities to produce compliance reports and metrics
• Lead and facilitate training sessions for manufacturing employees
• Assess training requirements and collaborate with managers on learning needs
• Design training programs covering SOPs, FDA cGMP, EHS regulations, and work skills
• Support authoring of Standard Operating Procedures for new processes and systems

Requirements

• High school diploma/GED plus 4+ years related experience, or Associate's degree in STEM with 1+ year experience
• Proficiency in Microsoft Office and ability to learn quality systems (TrackWise, ComplianceWire, JD Edwards, Unicorn)
• Knowledge of current Good Manufacturing Practices principles and best practices
• Foundational understanding of manufacturing and laboratory operations
• Experience with deviation investigations and corrective/preventive actions
• Ability to author and edit Standard Operating Procedures under guidance
• Physical ability to sit, stand, walk, lift up to 10 pounds frequently and 50 pounds occasionally