Auditor - Cqa

CSL Behring

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Conduct external clinical investigator site audits
Develop comprehensive audit reports with risk categorization
Identify non-compliance trends in clinical trial data
** CSL Behring is seeking an experienced CQA Auditor to join their Research & Development Quality audit program, responsible for ensuring compliance and accuracy in clinical trial data. The role involves executing audits, reporting findings, and supporting continuous improvement initiatives, requiring strong regulatory knowledge and communication skills. **

Job Summary

  • This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data.
  • The position requires identifying findings and non-compliance trends that could impact the integrity of clinical research across sites and vendors.
  • CSL values inclusion and belonging, fostering a culture of curiosity and empathy to sustain a diverse workforce.

Matching Summary

Match Score: 75

** CSL Behring is seeking an experienced CQA Auditor to join their Research & Development Quality audit program, responsible for ensuring compliance and accuracy in clinical trial data. The role involves executing audits, reporting findings, and supporting continuous improvement initiatives, requiring strong regulatory knowledge and communication skills. **

Skills & Requirements

Must-have

  • Conduct external clinical investigator site audits
  • Develop comprehensive audit reports with risk categorization
  • Identify non-compliance trends in clinical trial data
  • Maintain knowledge of ICH E6 GCP regulations
  • Manage schedule with up to 50% global travel

Nice-to-have

  • Strong interpersonal and negotiation skills
  • Ability to work collaboratively with multinational teams
  • Experience developing corrective and preventive actions
  • Support for continuous improvement initiatives

Key Requirements

  • BS degree in biological science or related discipline
  • Quality Assurance experience within a GCP-regulated environment
  • Experience in clinical audit and inspection management
  • Excellent communication skills for stakeholder engagement

Work Rights

Not specified

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