Associate Lead I - Biomanufacturing Compliance - Training
Catalent · Madison, WI
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Catalent's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.