Expert in Laboratory Management and Development: ISO and Internal Audits, Statistical Process Control, Sampling and Process Improvement
Expert managed and developed an analytical laboratory from department side service for basic soil analysis to independent profitable Laboratory unit for soil, plant and water analysis. The laboratory supported research and also performed testing services for national forest monitoring program and commercial clients. Expert interviewed, hired and on-boarded laboratory staff during this time.
Expert carried out extensive laboratory business analysis that included quality performance, work load and financial data. She found out that financial data lacked transparency and developed and implemented laboratory accounting and pricing systems. She proved profitability of the laboratory and prevented its closure.
Expert helped R&D company in Europe to develop testing services business. She delivered workshops on ISO/IEC 17025 compliant quality system for laboratory, moderated several brainstorming sessions, carried out SWOT analysis and gap analysis, and helped the client prepare business plans for the development of market-oriented laboratories for polymer testing.
Expert has managed laboratory renovation projects. She selected project team members and led efforts to redesign laboratory office spaces into testing area and acquire office space for laboratory engineers and the manager in a nearby office space of an R&D department. She selected contractors and coordinated laboratory remodeling.
Expert has experience in purchasing and managing installation of laboratory equipment including planning of investment and net present value analysis.
MEASUREMENT SYSTEM EVALUATION, EQUIVALENCE TESTING AND TEST METHOD VALIDATION:
Expert evaluated measurement systems in analytical and physical testing laboratories after implementation of new equipment, equipment replacement, parts and reagents replacement, major maintenance of equipment or replacement/addition of operator. She designed and evaluated many variability studies and measurement system analysis studies to identify either opportunities for improvement or to troubleshoot measurement process.
She implemented Evaluation of Measurement Processes methods to testing laboratory. She successfully used graphical presentations of measurement system performance data in communications with laboratory staff and management.
She performed many equivalence studies for equipment replacement, test method improvement, operator qualification and reagents replacement.
She designed experiments, analyzed data for test method validation and reviewed test method validation plans and statistical reports for laboratories in environmental, polymer and pharmaceutical industry.
QA/QC FOR TESTING PROCESES
Expert developed and implemented QA procedures including check sample and internal reference material preparation and preservation, selection of control charting tools for monitoring test method performance, data collection plan, out-of-control action plan, data analysis and reporting.
Expert successfully implemented QA program in environmental laboratory and improved its performance from low performing in proficiency testing program to top performing laboratory.
Expert worked with client in polymer industry and evaluated performance of several test methods in development. She prepared routine quality control implementation plan for laboratory services.
Expert developed training on implementation of QA program using control charting and risk management in testing laboratories and trained many laboratory professionals.
Expert is technical contact for ASTM E2587 standard for control charting methods.
Expert was representative of Republic of Slovenia on several Expert Panels for harmonization of methodology for sampling, laboratory analyses and quality control in European Forest Monitoring Program -ICP-Forests.
Expert developed, implemented and managed internal proficiency testing program for manufacturing company and its materials suppliers to monitor testing performance. She used ASTM methods for analysis of data and reporting.
Expert managed proficiency testing activities for analytical and materials testing laboratory including troubleshooting of non-performing test results and monitoring overall laboratory performance.
Expert organized and managed round robin studies between production materials testing laboratory and supplier laboratory.
Expert was a member of The Alliance for Life Sciences, Food, Veterinary and Agriculture Expertise (ALVA) and prepared soil and plant tissue samples for ALVA proficiency testing scheme.
Expert developed soil sampling design optimization by using composite samples subject to predetermined budget constrain. She used multivariate statistical methods and Bayesian approach to determine sampling design information. This work was continuation of her previous study on evaluation of sampling design performance for several analytes. She had invited presentation of this work at US Air Force Environmental Training Symposium in 2005 and at annual expert conference of The Alliance for Life Sciences, Food, Veterinary and Agriculture Expertise (ALVA).
Expert prepared sampling designs for environmental impact studies, phytoremediation project, and material evaluation in production troubleshooting. She developed sampling design for evaluation of rubber sheets spatial variability that was used in planning production transfer to another facility.
Expert developed laboratory procedures for preparing and evaluating internal laboratory reference materials, proficiency testing sample material and laboratory check samples.
She developed sampling plan and a suite of test methods to identify and quantify deviation in raw material properties from a supplier causing processing problems and delays in production. Her work was vital for resolving the issue with one of the suppliers, which eventually eliminated reprocessing of material and reduced scrap cost.
DEVELOPMENT AND IMPROVEMENT OF ISO/IEC 17025 COMPLIAN QUALITY SYSTEMS
Expert developed, deployed and managed ISO/IEC 17025 compliant quality system for environmental laboratory in Europe. She also managed proficiency testing and QA activities and developed or improved many laboratory policies and procedures for ISO/IEC 17025 accredited laboratory in US. She was also point of contact for laboratory accreditation and lead auditor for internal audits of two accredited laboratories.
Expert prepared reports on laboratory performance for management review with many graphical presentations of performance metrices and comparisons to historic performance. She developed training efficiency metrices and QA and PT performance metrices.
As a consultant, Expert has:
- developing testing servicess buisness: auditing to evaluate gaps in quality system, SWOT analysis, business plan for development of testing services, planning for purchasing and iunstallation of equipment, net present value analysis of investment,
- evaluating pottential for metger of two laboratories
- developing or improving quality system: preparing policies, procedures, implementing QA procedures, risk management procedures, ...
- planning remodeling of laboratory/testing facility
- business analysis - quality performance, work load, profitability, training efficiency
Expert may consult nationally and internationally, and is also local to the following cities: Denver, Colorado - Colorado Springs, Colorado - Fort Collins, Colorado - Grand Junction, Colorado - Boulder, Colorado - Portland, Oregon - Detroit, Michigan - Columbus, Ohio - Cleveland, Ohio - Dayton, Ohio
|Year: 2006||Degree: MBA||Subject: Business with Management Information Systems specialization||Institution: Bowling Green State University|
|Year: 2001||Degree: PhD||Subject: Agriculture / Soil science||Institution: University of Ljubljana, Slovenia|
|Year: 1996||Degree: MSc||Subject: Agriculture / Soil science||Institution: University of Ljubljana, Slovenia|
|Year: 1992||Degree: BSc||Subject: Chemistry / Analytical Chemistry||Institution: University of Ljubljana, Slovenia|
|Years: 2011 to 2018||Employer: Self Employeed||Title: Owner, Managing Principal and Laboratory Consultant||Department:||Responsibilities:|
|Years: 2018 to Present||Employer: Undisclosed||Title: Quality Management Specialist||Department:||Responsibilities:|
|Years: 2007 to 2011||Employer: COOPER TIRE AND RUBBER CO||Title: Senior chemist||Department: Materials Laboratory||Responsibilities: - Deputy laboratory manager
- Point of contact for laboratory accreditation
- managing quality assurance and proficiency testing activities for testing services
- Internal auditing
- conducting variability studies of raw materials for production troubleshooting
-developing and troubleshooting test methods
|Years: 2005 to 2006||Employer: Bowling Green State University||Title: Applied Statistics||Department: Graduate Assistant||Responsibilities: - grading homeworks and exams for undergraduate students
- conducted research on EWMA control charts and published paper with Dr. Arthur Yeh
|Years: 1995 to 2005||Employer: Slovenian Forestry Institute||Title: Laboratory manager||Department: Laboratory for Forest Ecology||Responsibilities: - managing daily operations
- strategic planning
- laboratory development
- implementation of ISO/IEC 17025 compliant quality system
- national representative in expert panels for sampling and quality of laboratory testing for European Forest Monitoring program
|Years: 1992 to 1995||Employer: Slovenian Forestry Institute||Title: Analytical chemist||Department: Department for Forest Ecology||Responsibilities: - managing testing services
- analyzing soil and plant samples
- implementing net analytical methods
- managing laboratory data and preparing laboratory reports
|Years: 2007 to 2018||Employer: Expert's own consulting firm||Title: Owner and Managing Principal||Department:||Responsibilities: - management of daily operations
- business development and marketing
- laboratory quality consulting
-applied statistics for testing laboratories
- training development and delivery
|Years: 2018 to Present||Employer: Undisclosed||Title: Quality Management Specialist||Department:||Responsibilities: - consulting to laboratory clients
- review of scientific reports
- laboratory assessments
- applied statistics
- R-code verification for reproducibility
|Years: 2003 to 2004||Agency: Slovenia / Agricultural and Environmental Ministry||Role: Member of EU pre-accession negotiations team for the area of forest monitoring;||Description: Worked with consultants from the Netherlands and Slovenian government on assuring funding for forest monitoring program in Slovenia. Responsible for implementation of testing methods and QA/QC rquirements for European Forest Monitoring program. Coordinating and leading meetings with State Secretary for Environment.|
|Associations / Societies|
|- ASTM International member (2007 to present)
- Beta Gamma Sigma (2006 to present)
- Society of Military Engineers (2017 to present)
- The Alliance for Life Sciences, Food, Veterinary Expertise and Agriculture (ALVA) (1995 – 2005)
|Licenses / Certifications|
|A2LA lead assessor, May 2019|
|- ASTM Committee, E11 Quality and Statistics, Secretary (2015 to present),
- Member of the Executive Committee of the Slovenian Statistical Society (2001-2005);
- Representative of Republic of Slovenia on several Expert Panels for harmonization of methodology for sampling, laboratory analyses and quality control in European Forest Monitoring Program -ICP-Forests (1993-2005);
|Awards / Recognition|
|- 2 Cooper Way Coins for outstanding performance
- Young researcher grant for MSc and PhD education, awarded by Slovenian Ministry of Science
- Research grant for 6-month work on PhD thesis at Center for Statistical Ecology and Environmental Statistics, Penn State University, awarded by Slovenian Ministry of Science
- Krka Pharmaceuticals award for BSc degree thesis, 1st prize
|Publications and Patents Summary|
|18 journal articles
3 book chapters
33 published conference articles
1 expert opinion for arbitration
6 technical report