GCP Auditor Resume

Samantha Gray

North Highlands CA 95660

(916) 987-6543

[email protected]

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Job Objective

Qualified GCP Auditor seeking work with an established firm in which to put my skills and knowledge to good use.

Work Experience:

GCP Auditor, August 2005 – Present

Idexcel, Dallas, TX

  • Planned and conducted external audits of clinical studies and third parties.
  • Performed internal audits within the affiliate and at Country Offices in the affiliating territories.
  • Provided advice and implemented compliance issues and the Quality Management System (QMS).
  • Prepared and conducted audits and inspections.
  • Ensured the safety, well-being and legal protection of subjects and the validity of study data.
  • Ensured escalation of business critical compliance issues.

GCP Auditor, May 2000 – July 2005

Roche, Dallas, TX

  • Performed assigned audits on internal GCP systems, external vendors and clinical sites.
  • Utilized available information to provide well-informed audit findings and recommendations.
  • Reviewed and verified GCP reports.
  • Evaluated requirements of the protocol, informed consent form, case report forms, and essential documents.
  • Assisted Inspection Management Team in regulatory authority inspections.
  • Presented observations to appropriate representatives and prepared a written audit report.

Summary of Qualifications:

  • Remarkable experience working in a clinical, regulatory and quality assurance environment
  • Excellent knowledge of GCP auditing
  • Good understanding of GCPs, ICH and procedures and practices in a clinical research setting
  • Skilled in monitoring and auditing of EU and other non-US clinical trials
  • Sound knowledge of FDA regulations, ICH guidelines, and corrective action plans, etc
  • Sound ability to prioritize and understand work impact
  • Ability to work under pressure and independently
  • Excellent communication and intrapersonal skills
  • Excellent report writing capabilities


Bachelor’s Degree in Physical, National American University, Rapid City, SD