Lead - Biomanufacturing Compliance - Investigator, Deviations Job at Catalent, Madison, WI

  • Catalent
  • Madison, WI

Job Description

Lead compliance investigator for biomanufacturing operations at a GMP biologics facility. Responsible for authoring deviation records, managing investigations, and ensuring cGMP compliance across manufacturing processes. Collaborates with quality and manufacturing teams on corrective actions and inspection readiness.

Responsibilities

  • Author and revise deviation records, preventative actions, and related cGMP documentation
  • Track and monitor investigation status, providing timely updates to stakeholders
  • Lead compliance culture improvement initiatives and cGMP training efforts
  • Organize and lead inspection readiness activities and associated teams
  • Support internal and client audits regarding deviations and corrective/preventive actions

Requirements

  • High school diploma/GED plus 7+ years related experience, or Associate's in STEM plus 6+ years
  • 3+ years experience with Bachelor's in STEM, or MS/PhD in technical discipline
  • Demonstrated expertise in deviation writing, root cause analysis, and CAPA implementation
  • Proficiency in Microsoft Office and quality systems like TrackWise, ComplianceWire, JD Edwards, Unicorn
  • Strong knowledge of cGMP principles and manufacturing/laboratory operations
  • Experience authoring, revising SOPs and technical documentation
  • Ability to read, write, and communicate clearly in English

Job Tags

Work at office

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