American Regent

QA Batch Record Review II

American Regent(1 month ago)

New Albany, OHOnsiteFull TimeMedior$83,746 - $113,456 (estimated)Quality Assurance
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About this role

The QA Batch Record Reviewer II at American Regent ensures that batch record documentation for sterile pharmaceuticals complies with SOPs, cGMPs, and regulatory requirements. The role involves critical review of records, updating metric reports, supporting investigations and CAPAs, and mentoring less senior staff while collaborating across multiple departments.

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Required Skills

  • Batch Record Review
  • Data Entry
  • Metric Reporting
  • Process Improvement
  • SOP Compliance
  • cGMP Knowledge
  • Microsoft Excel
  • Microsoft Word
  • Investigation Support
  • Mentoring

+2 more

Qualifications

  • High School Diploma
  • Associate Degree (Preferred)
  • Bachelor's Degree (Preferred)

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