Mikayla Lee

Managed high-throughput laboratory operations and cross-functional projects, supporting a custom LIMS build and maintaining performance, quality, and turnaround time targets. Led quality and process improvement efforts (including CAPA/RCA and SOP documentation), including improvements increasing production by 45% and decreasing errors by 60%.

Supported lab start-up operational development and led multiple concurrent initiatives across cross-functional teams to deliver on-time quality outcomes. Drove Lean/continuous improvement (Hoshin Kanri), led change management and training, and authored RCA/CAPA documentation; reduced employee turnover by 20%.

Led cross-functional overnight team delivery, including successful turnaround of up to 800 samples within an 8-hour timeframe. Improved application performance by identifying bottlenecks and optimizing code, while establishing documentation and quality standards.

Performed molecular diagnostics lab work with an emphasis on documentation, safety, quality control checks, and maintaining an organized work environment for accurate test results. Trained new laboratory personnel on proper laboratory techniques and best practices.

Supervised specimen preparation and test analyses to maintain acceptable analytic performance and ensured corrective actions were executed/documented when performance specifications were not met. Maintained compliance with CLIA, OSHA, and HIPAA via daily logs, instrument verification, and SOPs, and processed SARS-CoV-2 using LumiraDx Deep Well Format and LuminUltra GeneCount Q-96.

Managed daily performance of approximately 20 staff members and ensured site OSHA compliance through operational oversight. Oversaw performance records, materials and equipment, attendance and HR/payroll matters, and supported routine checks, diagnostic testing, and insurance/billing record management.

Scribed in the emergency department, translating medical jargon into correct terminology and supporting charting/billing criteria using medical codes. Managed inquiries via computer and phone systems and used Cerner for records management.

Grade: 3.87 GPA

Earned a Master of Science in Biotechnology. Relevant coursework included Clinical and Molecular Diagnostics, Bioassay Development, Infectious Diseases, and Gene Therapy (GPA: 3.87).

Earned a Bachelor of Science in Biology from the University of Central Florida (completed May 2020).

Completed a Clinical Trials Data Management and Quality Assurance certificate program via Coursera.

Completed a Design and Conduct of Clinical Trials certificate program via Coursera.