Quality Auditor

Aldevron

Fargo, United States
Fully remote
Quality management system audits
Cgmp compliance
Ich q10
The Quality Auditor is responsible for ensuring the integrity and effectiveness of Aldevron’s Quality Management System by planning and executing internal and external audits that drive continuous compliance and operational excellence

Job Summary

  • The Quality Auditor is responsible for ensuring the integrity and effectiveness of Aldevron’s Quality Management System by planning and executing internal and external audits that drive continuous compliance and operational excellence.
  • Plan, coordinate, and conduct internal and external QMS and product-focused audits, ensuring compliance and effectiveness by following internal SOPs and relevant auditing standards.
  • Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.

Matching Summary

The Quality Auditor is responsible for ensuring the integrity and effectiveness of Aldevron’s Quality Management System by planning and executing internal and external audits that drive continuous compliance and operational excellence.

Skills & Requirements

Must-have

  • Quality Management System audits
  • cGMP compliance
  • ICH Q10
  • 21 CFR Part 210/211
  • FDA and EU regulatory standards

Nice-to-have

  • Continuous improvement culture
  • Collaborative spirit
  • Drive progress
  • Innovating at the speed of life

Key Requirements

  • Bachelor’s Degree required
  • ASQ Certified Quality Auditor preferred
  • Experience in a cGMP environment
  • Experience in a quality role
  • Experience in Compliance, Supplier Management, and Regulatory Affairs preferred
  • Experience working with FDA and regulatory agencies

Work Rights

Not specified

Tailored Resume

Cover Letter