QA Auditor Resume

Posted in Auditor Resume Examples

Leslie Travis
2526 Graystone Lakes
Macon, GA 31204
(111)-777-5407
[email]

Job Objective Seeking a position with company in which to exercise my experience and training as a QA Auditor.

Summary of Qualifications:

  • Sound knowledge of FDA, EMeA and other international Quality System rules and regulations
  • Remarkable experience in Quality Assurance and Compliance in an auditing capacity
  • Proficiency in MS word, spreadsheet and database management software
  • Thorough knowledge of GMP regulations, protocols and SOPs
  • Ability to interact with all project teams, investigators, vendors, and clients
  • Strong attention to detail
  • Good interpersonal skills
  • Excellent written and oral communication skills

Work Experience:

QA Auditor, August 2005 – Present
Regeneron Pharmaceuticals, Macon, GA

  • Planned scheduled, prepared and conducted audits in support of GCP, GLP and GMP as directed.
  • Conducted audits in accordance with standard operating procedures and quality policies.
  • Managed to appropriately escalate compliance issues.
  • Communicated audit results to management through written audit reports.
  • Managed post-audit activities and follow-up on any necessary corrective and preventive actions.
  • Resolved conflict issues.

QA Auditor, May 2000 – July 2005
Icon, Macon, GA

  • Performed QA audits of in compliance with established study protocols.
  • Conducted evaluations to ensure site as per established standards.
  • Involved in project audit management.
  • Ensured that audit results are formally recorded and reported and that corrective actions (CAPA) are documented.
  • Trained the staff with GLP, ISO 9000, role of QA, regulatory audits, etc.
  • Ensured to adhere to Good Laboratory Practice (GCP) regulations and guidelines, and ISO 9000 requirements.

Education

Bachelor’s Degree in Life Science, Averett University, Danville, VA


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