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QUALITY SCIENTIST

Results focused and detail oriented professional with extensive medical experience in instrumentation, technical writing, and laboratory processes. Proficient in troubleshooting and repairing medical instrumentation, with strong working knowledge of chemistry assays, cGMP and ISO9000 Quality Systems, and investigating on-market product complaints. Skilled in developing and presenting educational programs to both technical and non-technical personnel. Highly reliable in ensuring compliance with regulations and standards affecting in-vitro diagnostics and biologics. A proven leader and an excellent communicator recognized for ability to establish and maintain effective working relationships across cross-functional teams and diverse individuals at any levels.

Core Competencies
Project Management & Coordination • Quality Control/Assurance Investigations • Process Evaluation
• Needs Assessment • Documentation • Reports Development • Risk Management • Training Delivery

PROFESSIONAL EXPERIENCE

Abbott Laboratories, Irving, TX 11/2004 – Present
Quality Scientist – Investigations, 03/2007 – Present
Perform investigations on customer complaints regarding on-market Clinical Chemistry reagent performance. Develop investigational summary; analyze data, evaluate results, formalize and present conclusions.
• Ensure adherence to CAPA processes while analyzing impact of failure across chemistry product line.
• Handle exception reports including creating, inputting data and routing to completion of base investigation.

Customer Technical Advocate, 11/2004 – 03/2007
Managed critical accounts involving top tier customer service and support. Facilitated hematological technical training for peer technical support team members.
• Trained internal and external employees and customers on Cell-Dyn Hematological Analyzers.

U.S. Air Force Active Duty and Reserve 03/1997 – Present
Health Services Administrator (Compliance Officer), 01/2010 – Present
Maintain an effective compliance program. Develop, maintain and revise policies and procedures for the compliance program. Acts as an independent review and evaluation body ensuring any issues are appropriately investigated.
• Direct hospital accreditation programs and management improvement training

Clinical Laboratory Manager, 03/1997 – 01/2010
Develop and established laboratory policies and procedures for the entire laboratory/pathology section.
• Managed training, personnel, quality assurance and laboratory budgeting in excess of $6 million annually.

Baylor Medical Center, Grapevine, TX 07/2001 – 11/2004
Medical Technologist
Oversaw clinical chemistry, blood bank, and microbiology. Performed and analyzed diagnostical testing on body fluids in all areas of the lab. Maintained the highest standards of quality control, quality assurance and safety.

Arlington Memorial, Arlington, TX 07/1999 – 07/2001
Medical Technologist
Functioned as Microbiology specialist, including assisting Pathologist with autopsies and bone marrow collections. Served as 2nd Shift Lead Tech, and trained new employees on established lab procedures and guidelines.

EDUCATION AND CREDENTIALS

Columbia College – Fort Worth, TX
Masters of Business Administration
Bachelor of Science in Business Administration / Management Information Systems

Community College of the Air Force – Maxwell Air Force Base, AL
Associate of Arts and Science in Clinical Laboratory Science

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