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Associate I - Quality Assurance, On the Floor (3rd Shift)

Catalent · Madison, WI

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Role summary

Catalent seeks a Quality Assurance Associate I for third-shift on-site work in Madison, Wisconsin. The role involves executing QA programs, conducting manufacturing walkthroughs, reviewing batch records, and maintaining regulatory compliance in a biologics manufacturing facility.

What they're looking for

  • Bachelor's degree in STEM field with any experience level
  • OR Associate's degree in STEM with 1+ years experience
  • OR High school diploma with 4+ years experience
  • Knowledge of FDA and regulatory compliance requirements
  • Ability to work third shift (Wednesday-Saturday, 8PM-6AM)

What you'll be doing

  • Execute QA on the floor program and conduct manufacturing walkthroughs
  • Review batch records, test data, and production logs for compliance
  • Issue controlled production documents including batch records and labels
  • Inspect final product containers and release solutions and materials
  • Escalate quality and regulatory issues to appropriate departments

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