Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

SHANNON LEE

Owensboro

Summary


With over nine years of experience as a Microbiologist and Quality Supervisor, and nearly six years as a Medical Laboratory Scientist, I bring a results-driven, analytical approach to microbiology, diagnostic testing, and regulatory compliance. My professional journey bridges the clinical, industrial, and regulatory sectors, and I am now eager to apply this multidisciplinary background to the field of forensic science through graduate study at the University of Florida.

In my current role at Mizkan, I lead the design, implementation, and maintenance of comprehensive food safety and quality assurance programs. This includes managing HACCP plans, calibrations, environmental and allergen monitoring programs, and performing detailed root cause analyses. I’ve resolved consumer complaints through validated corrective and preventive actions, while collaborating closely with R&D teams to ensure process integrity. My work has consistently ensured compliance with regulatory agencies and certifications, including FDA, USDA, FSSC 22000, CCOF Organic, ISO, GMPs, and Standard Sanitation Operating Procedures. Additionally, I’ve led initiatives for sterilization validation, contamination control, and pathogen mitigation. I am known for realiability, and strong problem solving skills, process improvement/regulatory compliance.

As a Medical Laboratory Scientist, I performed a broad spectrum of diagnostic testing in clinical microbiology, hematology, chemistry, toxicology, urinalysis, blood banking, and molecular diagnostics. I ensured the accuracy and timeliness of results, troubleshooted instrumentation issues, and maintained compliance with CLIA, CAP, and Joint Commission standards. I also trained and mentored technologists, assisted with equipment validations, and refined workflows. Collaborating with healthcare professionals, I contributed to improved patient outcomes and lab efficiency.

My experience with method validation, evidence-based analysis, contamination control, and quality improvement has prepared me to thrive in forensic science. I bring a deep commitment to scientific integrity, and I am excited to advance my expertise in this field.

Overview

16
16
years of professional experience
1
1
Certification

Work History

Quality Supervisor and Microbiologist

Mizkan Inc.
02.2015 - Current
  • Optimized finished product testing methods and lab equipment to ensure accuracy, efficiency, and compliance. Part of implementation of process for new lab equipment.
  • Helped design and maintained HACCP plans and flowcharts, incorporating updates based on new regulatory requirements and product innovations.
  • Played a key role in establishing and improving quality control systems, including SSOPs, GMPs, and allergen control programs.
  • Supervised and developed cross-functional teams to ensure consistent adherence to quality standards and regulatory compliance.
  • Led the plant’s sanitation program, ensuring compliance with rigorous cleanliness standards.
  • Conducted comprehensive environmental swabbing programs, analyzing data to identify trends and implement preventive actions.
  • Participated in FDA, FSSC 22000, CCOF Organic, and supplier audits, ensuring all regulatory and quality standards were met.
  • Conducted risk assessments on raw materials and new product implementations, partnering with supply chain and R&D teams.
  • Conducted root cause analyses to identify opportunities for improvement and drive operational changes.
  • Implemented corrective/preventative actions to address product deviations and improve processes.
  • Partnered with vendors to address non-conformance issues and ensure raw materials met stringent quality standards.
  • Worked closely with R&D teams on various projects and plant trials, conducting testing, providing insights, and ensuring successful implementation of new processes and products.
  • Led investigations into foreign material identification and consumer complaints, implementing actionable solutions that improved product safety and customer satisfaction.
  • Conducted vendor complaints and part of the new vendor approval process.
  • Developed and delivered training sessions on HACCP, GMP, allergens, and food defense for plant associates.
  • Compiled and presented detailed reports and statistical analyses to cross-functional teams and senior leadership.
  • Enhanced operational efficiency by improving laboratory processes and collaborating on annual QA budgets.
  • Successfully implemented new allergen and environmental monitoring programs, increasing compliance and safety.
  • Spearheaded initiatives to reduce consumer complaints and improve product quality through effective root cause analysis.
  • Played a critical role in preparing for and successfully passing FDA, FSSC 22000, CCOF Organic, and supplier audits.
  • Developed CAPA plans that resolved critical production and quality issues, driving continuous improvement.

Medical Laboratory Scientist

The Medical Center Hospital
09.2011 - 02.2015
  • Performed comprehensive laboratory testing across all major departments, ensuring accurate and timely diagnostic results for patient care.
  • Conducted diagnostic testing across all laboratory disciplines.
  • Collaborated with physicians, nurses, and other healthcare professionals to support clinical decision-making.

Temporary Production Assistant

Carhartt
09.2010 - 03.2011
  • Assisted in the packaging and ensured quality of a variety of products.
  • Answered questions/concerns involving Carhartt products.
  • Helped vendors with a variety of needs.

Middle School Math Teacher

Chandlers Elementary
06.2010 - 12.2010
  • Prepared lesson plans and taught grades 6-8 Mathematics.

Middle School Math/Science Teacher

Union County Middle School
06.2009 - 06.2010
  • Grades 6-8 Math/Science Instructor, E.S.S.
  • Tutor, Christian Club leader.

Education

Bachelor of Science - Math/Science Education with Additional coursework for Medical Laboratory Scientist Certification (ASCP)

Murray State University
Murray, KY

Associate in Medical Laboratory Science - Additional coursework for Medical Laboratory Scientist Certification (ASCP)

Madisonville Community and Technical College

Skills

  • Regulatory Compliance: FDA, FSMA, FSSC 22000, CCOF Organic
  • Quality Assurance Processes: HACCP, SSOP, SOPs, GMP, Food Defense/Security, Audits, data analysis, record review
  • Quality management systems
  • Corrective actions
  • Calibration management
  • Six sigma methodologies
  • Test method validation
  • Validation protocols
  • ISO standards
  • Supplier quality management
  • Data Analysis: Proficient in Microsoft Office, Excel, SAP, Tableau, Red Zone, Visio
  • Technical Expertise: Environmental sampling, food microbiology, allergen testing, lab equipment troubleshooting/optimization, microbiological, analytical, and diagnostic testing
  • Leadership: Team building, associate training, cross-functional collaboration, Root Cause Analysis, ISO Standards, Validation Protocols, Calibration Management, Preventive Actions, Sampling Plans, Procedure Development
  • Product sampling
  • Statistical process control

Certification

  • Medical Laboratory Scientist (ASCP)
  • HACCP (Hazard Analysis and Critical Control Points)
  • PCQI (Preventive Controls Qualified Individual)
  • FDA Better Process Control School
  • DEKRA Leadership Safety Training
  • Advanced Thermal Processing (TechniCAL)
  • Food Defense, Sanitation, and Environmental Monitoring

Timeline

Quality Supervisor and Microbiologist

Mizkan Inc.
02.2015 - Current

Medical Laboratory Scientist

The Medical Center Hospital
09.2011 - 02.2015

Temporary Production Assistant

Carhartt
09.2010 - 03.2011

Middle School Math Teacher

Chandlers Elementary
06.2010 - 12.2010

Middle School Math/Science Teacher

Union County Middle School
06.2009 - 06.2010

Associate in Medical Laboratory Science - Additional coursework for Medical Laboratory Scientist Certification (ASCP)

Madisonville Community and Technical College

Bachelor of Science - Math/Science Education with Additional coursework for Medical Laboratory Scientist Certification (ASCP)

Murray State University
SHANNON LEE