2526 Graystone Lakes
Macon, GA 31204
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
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.
Bachelor’s Degree in Life Science, Averett University, Danville, VA