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Yyyyyy x. yyyyyy

 

0000 xxxxxx xxxx , xxxx , xxxxx 00000

xxx-xxx-xxxx

abc@xyz.com

 

Auditing and Quality Assurance

 

Profile of Qualifications

 

Many years of experience in quality assurance, operations management, staff leadership, auditing, personnel instruction, project management, process improvement, strategic planning and inspections. Excellent planning, organization, time management and decision-making skills. Strategically coordinate with various professionals to maximize performance in facilitating goals and attaining operational excellence. Well-versed in effective organizational collaboration. Self-driven team player with strengths in communication and developing interpersonal relationships. Member of American Society for Quality. Winner of Exceptional Leadership Award, QA Star Award, ARC Tiffany Award for Management, Outstanding Leadership Award and two Letters of Appreciation.

 

Career Track

 

American Red Cross, Charlotte, NC 1992 - Present

Senior Quality Assurance & Principal Auditor, Biomedical Headquarters, 2007-Present

       Execute detailed audits in coordination with host site and drive adherence to Federal, AABB & company parameters.

       Knowledgeably instruct Charlotte DCSC QA, provide key input to Testing Process Council for NTL and assist in developing Controls Template for Product Testing.

       Formulate & oversee baseline processes for Diagnostic Manufacturing Division and CQSA Job Shadowing Program.

 

Quality Assurance Director, National Testing Laboratory, 2003-2007

       Tasked with directing facility QA & QC operations, professionally developing personnel, planning initiatives, performing audits, securing licenses and enhancing processes.

       Knowledgeably prepared & delivered comprehensive training sessions to staff members and collaborated with headquarters to enact Quality Assurance efforts.

       Chosen to present "Hosting a Successful FDA Inspection" at 2007 National Quality Meeting & Quality Academy.

       Served on Process Councils for Sample Management &Confirmatory Testing, Lean Steering Committee and Testing Quality & Compliance Oversight.

 

Quality Assurance Officer, National Testing Laboratory, 1998-2003

       Effectively supervised QA, including all aspects of licensure, auditing, monitoring and regulatory compliance.

       Successfully implemented new QA processes regarding yearly operations training for FDA & AABB inspections and served as interim Senior Quality Director for all National Testing Laboratories.

 

Q4 Specialist & Associate, National Testing Laboratory, 1995-1998

       Conducted detailed QA for internal audits, corrective actions, inspections & analyses and served on National Predictive Inspections Profile Committee.

 

Viral Laboratory Technologist, National Testing Laboratory, 1992-1995

       Expertly conducted tests, inventory management, supply acquisitions & personnel training for this facility.

 


Education

 

 

Certified Medical Technologist (MT, ASCP), American Society of Clinical Pathologists

Medical Technologist, Presbyterian Hospital School of Medical Technology

Certified Quality Auditor, American Society for Quality

Six Sigma Yellow Belt, ASQ

Cost of Noncompliance, American Society for Quality

National HR Instructor for Achieve Global Leadership Services

Problem Solving and Decision Making, Kepner-Tregoe

The Customer Total Quality Service, Integrity Systems

ISO 9000 Lead Auditor Training, Irish Society for Quality

 

Bachelor of Science - Biology, University of North Carolina at Charlotte

 

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