Kathryn Gumpper

President and Consulting Chemist

Resume

Full-time since 2006, Ms. Gumpper works with laboratory quality systems, performs data validation, and provides training services to various laboratories ranging from small wastewater labs to large, full-service environmental laboratories, clinical laboratories and food laboratories. Her experience with laboratory quality systems includes designing, implementing, maintaining and auditing quality systems for laboratories operating under the NELAC and ISO 17025 Standards, as well as CAP/CLIA. Ms. Gumpper is trained, certified and has extensive experience performing ISO accreditation assessments to the requirements of ISO/IEC17025 - Chemical and Biological Testing Laboratories, Department of Defense QSM version 5, ISO 17043 - Proficiency Test Providers, ISO 15189 - Clinical Laboratories, and ISO Guide 34 - Certified Reference Material Producers as a contractor for the American Association for Laboratory Accreditation (A2LA) and assessments to the requirements of NELAP for various State Accreditation Bodies. She has also performed numerous first and third party internal audits and accreditation gap audits.

Ms. Gumpper worked from 1985 to 1989 at DataChem Laboratories, beginning as a technician in organic analysis, later moving into Quality Control and project management. Her responsibilities included analyzing environmental samples using GC and GC/MS instrumentation, writing and reviewing standard operating procedures, assuring data quality and acting as customer liaison for the EPA-Contract Laboratory Program. From 1989-1995, she did method development, performed routine clinical assays, and was responsible for developing the quality assurance systems for the University of Utah Flow Cytometry Laboratory, and from 1995-1996 she performed routine molecular assays for the University of Utah Hematopathology Laboratory. From 1996-2006 Ms Gumpper was employed by Myriad Genetics, Inc where she served in progressively more responsible positions from Data Analyst to Director of Laboratory Operations for the clinical testing division. Her responsibilities there included designing and implementing proprietary data analysis software, managing the data analysis department and later managing all clinical and CODIS laboratory operations

Ms. Gumpper holds a Bachelor of Science degree in Psychology from Brigham Young University in Provo, Utah. She has taken extensive coursework in Biology and Chemistry (>50 semester hours) at BYU, University of Utah and Westminster College. She is a registered Medical Technologist in the field of Immunology (I, ASCP), a member of The Nelac Institute (TNI) and an Accreditation Council member of A2LA.


Publications and Contributions