North Highlands CA 95660
Qualified GCP Auditor seeking work with an established firm in which to put my skills and knowledge to good use.
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