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Catalent4 days ago

Associate Lead I - Biomanufacturing, Compliance

On-site · Madison, Wisconsin, United States

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Enterprise

Job Summary

Associate Lead I - Biomanufacturing, Compliance role based in Madison, WI on-site. Contributes to forward-facing compliance in a cGMP biomanufacturing environment, facilitates rapid response for deviations, tracks investigations, participates in inspections readiness, assists with CAPAs, SOPs, and on-floor manufacturing support. Requires knowledge of GMP principles, deviation investigations, CAPA, SOP writing/editing, quality systems (e.g., TrackWise, ComplianceWire, JD Edwards, Unicorn), and strong communication to ensure compliant, high-quality biologics production.

Required Qualifications

  • Minimum High School Diploma/GED with 4+ years related experience OR Associate’s degree in STEM with 1+ year related experience OR Bachelor’s degree in STEM with no experience required
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Catalent

Associate Lead I - Biomanufacturing, Compliance

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