Associate Lead I - Biomanufacturing Compliance, Lead Investigator

Associate Lead position in biomanufacturing compliance at Catalent's Madison biologics facility. The role involves authoring deviation records, managing investigations, and ensuring cGMP compliance while supporting quality systems and regulatory readiness.

Responsibilities

• Author and revise deviation records, preventative actions, and cGMP documents with minimal supervision
• Track and monitor open investigations while providing timely status updates and maintaining accurate records
• Develop familiarity with upstream, downstream, materials management, and facility systems to ensure accurate work completion
• Support inspection readiness activities and internal/client audits as assigned
• Contribute to process compliance culture improvement and guide standard operating procedure documentation

Requirements

• High school diploma or GED with 4+ years related experience, or Associate's degree in STEM with 1+ year experience
• Experience writing deviations and implementing root cause analysis and corrective/preventive actions
• Proficiency in Microsoft Office and ability to learn TrackWise, ComplianceWire, JD Edwards, and Unicorn systems
• Applied knowledge of cGMP principles and manufacturing/laboratory operations
• Experience with deviation investigations and authoring/editing standard operating procedures
• Ability to read, write, and communicate clearly in English; comfortable with sustained computer work and occasional physical tasks