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Associate I - Quality Assurance, On the Floor

Catalent

Catalent seeks a Quality Assurance Associate for on-site manufacturing support in Madison, Wisconsin. The role involves executing QA programs on the production floor, conducting walkthroughs, reviewing documentation, and ensuring regulatory compliance with FDA requirements.

Responsibilities

  • Execute quality assurance on-the-floor program and conduct manufacturing walkthroughs
  • Issue and review controlled production documents including batch records and labels
  • Inspect final product containers and release materials meeting quality standards
  • Escalate quality and regulatory issues to appropriate personnel
  • Maintain controlled records and provide operational quality support

Requirements

  • Bachelor's degree in STEM field with any experience level
  • Associate's degree in STEM with 1+ years experience
  • High school diploma with 4+ years relevant experience
  • Knowledge of FDA and regulatory compliance requirements
  • Ability to conduct manufacturing walkthroughs and inspections
Vacancy posted 21 days ago
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