WORK EXPERIENCE

BD Medical: Quality Systems Specialist II Sandy, UT (08/2020-Current)

Mid-Level Quality Specialist focused on the reporting quality data to the Food and Drug Administration. Quality data packaged and analyzed in IBM’s SPSS, creating data process flows and graphs identifying clear failures in production processes of medical and diagnostic systems.

Involved in new process creation to streamline data flow from customer to cloud based storage for complaint validation and subsequent Medical Device Reports to the FDA and International regulatory bodies.

Currently working on six sigma green belt and Audit certifications.

Reckitt Benckiser Via Manpower: Contractor R&D OPS Assistant Salt Lake City, UT (02/2020-07/2020)

Executor of the creation, monitoring, and testing of stability studies for product reformulation.

Managed studies from R&D to full scale plant trials. Each study was designed to save the company $250k-450k per year.

Lead team trainings in implementation of a new LIMS platform-Labware.

Ensured all data, product, and test results were up to cGMP/GLP standards. Maintained the quality standards set by the FDA and other international governing bodies, throughout the process.

Dynamic Blending Specialists: R&D Formulation Scientist Vineyard, UT (06/2019-01/2020) Created new and innovative products for in-house consumption and third-party clientele. As product engineer and formulator designed high-end personal care and cosmetic products, carrying through from Research to Production. Worked with the quality team to meet national and international governing body standards for all products.

Reformulated old or ineffective products to improve efficacy, scent, quality, stability, and sustainability. Involved in strategic planning for onboarding new products/clients.

Acted as liaison between our company and partners to ensure the final product was both feasible and met our partner’s expectations.

Young Living Essential Oils: QC Instrumentation Chemist/Interim Scrum Lead Spanish Fork, UT (03/2016-03/2017)

Interim team lead over Mass Spectrometer (MS) Team (4 members)-Trained on methods, ran team meetings, reported statistics on results to upper management. Task management for team members. Result verification and approvals. Troubleshooting and maintenance on all Mass Specs, and Ultra-High Pressure Liquid Chromatographer (UPLC). Document control and quarterly lab analytics.

Ensured The day-to-day quality of ICP-MS and ICP-OES, Assay preparation, analysis, and data reporting. Method development for ICP -MS and OES-MS.

Instated chemical safety storage practices in compliance with OSHA and FDA standards.

Edwards LifeSciences: Quality Assurance Technician Draper, UT (07/2014-02/2016)

Performance of quality control assays and method development to ensure the safety and conformance to ISO 11615, ISO 11238, and ISO 11240 Part 4 standards.

Increased on-time-delivery from 80% to 99.9% per month. Reduced number of laboratory-caused retests by 30%. Developed manual method for testing for Heparin Activity-Research to SOP and Validation Development-used on incoming raw material and finished products.

Preformed quarterly risk analysis for all laboratory processes and procedures, NDRs, and CAPAs. Over training staff on new assays and SOP updates.

Cornerstone Research & Development: Analytical Chemist I Ogden, UT (07/2012-08/2013)

Quality Control Chemistry on raw materials and finished goods. Focused on instrumentation, method development and training.

Melaleuca: Quality Assurance-Microbiology Laboratory Intern Idaho Falls, ID (03/2012-06/2012)

Conducted various Quality Assurance assays to insure product and environmental safety. Equipment maintenance and validations.

Publications & Certifications

D.J. Washenfelder; J.M Barton (Myself); K. D. Boomer; J. K. Engeman; C. M. Hendrickson; N. M. Kirch; R. S. Rast; G. E. Reeploeg; R. M. Russell; J. S. Schofield; E. C. Shallman (2010). RPP-RPT-47844 Process History of the 241-AX Tank Farm Leak Detection Pits. Washington River Protection Solution, DOE.

Six Sigma Green Belt Certification: in progress

Audit Certification: in progress

First Responder Certification: Renewed 09/2020

EDUCATION Brigham Young University Graduate studies Department of Microbiology and Molecular Biology

Brigham Young University – Idaho (BYU-I) B.S. of Biology: 2011

Relevant Skills

● 9 years of professional experience in informatics, molecular biology, and chemistry.

Experience with JavaScript, R, and minor knowledge of python.

Proficient in data analysis from cloud-based platforms using SSIS.

Proficient in LIMS, R Suite, SQLite, Beekeeper Studio Ultimate, working knowledge of IBM’s SPSS, SAS.

Experience building data pipelines.

Quality Assurance, Quality Control, cGXP, Data Analysis, Analytical and Root cause Analysis.