Ashley Francis
Loganville
Summary
Highly focused, detailed-oriented quality management specialist with over 10 years of credible experience in implementing a quality management system, including document management and risk management in regard to ISO 17025 and CLIA ’88. Experience working in multiple GLP/CLIA/ISO laboratories from the medical industry, public health industry, and biotechnology industry. Extremely familiar with laboratory procedures from related work experience and training acquired from Bachelor of Science in Biological Sciences.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Quality Management Specialist
Tanaq Support Services / Karna, LLC, Atlanta, GA
06.2019 - Current
- Company Overview: Centers for Disease Control and Prevention
- Co-facilitated in successful CMS Audit with no findings (July 2021 & September 2024)
- Monitor and maintain 7 CLIA laboratory tests according to CLIA 42 CFR Part 493 regulation
- Initiated and obtained ISO 17025 for 1 test system
- Develop, implement, and monitor the electronic, traceable specimen management via ELIMS.
- Develop and coordinate standard operating procedures to document management of quality throughout the life cycle of infectious diseases laboratories’ processes.
- Lead the document management program in ELIMS and AQuaRIUS for the Pneumonia and Streptococcus Laboratory Branch (PSLB), including developing document processes, standardized procedures, standardized templates, forms, job aids, and work instructions applicable for a wide range of laboratory applications.
- Assist and monitor the reporting of non-conformance events (NCEs)
- Assist with the development and the implementation of the Quality Indicators assessment
- Prepared and presented the Quality Management Review 2022 and 2023 for PSLB
- Provide and maintain training for PSLB
- Develop and maintain the equipment maintenance system, including performing monthly audits on the equipment.
- Implement and facilitate branch wide monthly quality meetings.
Quality Assurance Specialist
Omega Bioservices, Norcross, GA
01.2018 - 05.2019
- Operations Manager- monitored and managed 7 employees
- Created and Implemented Quality Management System, including a document control system
- Developed and performed quality assurance (QA) training and safety training for employees, to ensure lab staff follow safety and QA procedures
- Lead the internal quality and safety assessments
- Monitored all lab performances to ensure employees were properly trained and always complying with GLP regulation and CLIA requirements
- Created and implemented corrective action and preventative action (CAPA) system
- Reviewed and modified all Standard Operating Procedures
- Managed and completed external customer audits and quality questionnaires
- Assisted lab supervisor in calibration and preventative maintenance on all equipment/instruments
- Implemented LIMS system
- Human Resource and Administrative responsibilities
Senior Laboratory Technician
Battelle Memorial Institute, Atlanta, GA
10.2012 - 04.2016
- Company Overview: Centers for Disease Control and Prevention
- Developed, Implemented, and updated Laboratory SOPs
- Developed Collection Protocols for CDC Research Studies
- Supplemented IRBs
- Proficient using STARLIMS, LSTARS, Frontends, ATLIS, Canvas, Extranet databases
- Mentored new employees and CDC federal employees
- Provided support to all CDC studies within IRATB and DLS in the form of shipping, receiving, and preparing aliquots following CLIA regulations.
- Handled laboratory specimens including whole blood, urine, serum, breast milk, meconium, and cerebrospinal fluid.
- Maintained exceptional records and documentation
- Highly Proficient in phlebotomy
- Proper autoclave and decontamination techniques
- Followed all confidentiality guidelines as it relates to data.
- Adhered to the Universal Precautions regarding the handling of biological samples and biological waste.
- Adhered to CDC/NCEH/DLS and CLIA ’88 guidelines with regard to laboratory protocols and quality control.
Medical Assistant
Family Medicine Specialists, P.C., Fayetteville, GA
02.2010 - 02.2012
- Prepared patients for examinations and assisted during diagnostic examinations.
- Collected and prepared laboratory specimens including blood, urine, and feces.
- Performed basic laboratory tests such as urinalysis, urine microscopy, lipid panel, and hemoglobin A1c tests.
- Administered injections and drew blood from patients.
Education
Bachelor of Science - Biological Sciences (Human Biology)
Emory University
Atlanta, GA01.2009
Skills
- Monitor Non-conformances
- Laboratory internal assessments
- Proficient in Document Management
- Versed in ISO 17025
- Well-versed in CLIA CFR 42 Part 493
- Development of standard operating procedures
- Exceptional Organizational Skills
- Highly Proficient in Laboratory Practices
- Proficient in ELIMS
- Dedicated work ethic
- Self-directed and team-oriented
Accomplishments
Laboratory Quality Management System (LQMS) Certification March 2022
(CLSI) Laboratory Internal Auditing (CLSI) April 2023
Abstract/ Poster: September 2025
September 2025. Kathleen Thurman MS1, Ashley Francis BS1,2, Genevieve Langley BS1, Melisa Willby PhD1, Maureen Diaz PhD1 Development and Use of Quality Indicators to Strengthen Laboratory Quality Management Systems and Drive Continual Improvement. 1 Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA ,2 Tanaq Support Services, LLC.
Certification
- Laboratory Quality Management System (LQMS) Certification March 2022
- (CLSI) Laboratory Internal Auditing (CLSI) April 2023
- Abstract/ Poster: September 2025. Kathleen Thurman MS1, Ashley Francis BS1,2, Genevieve Langley BS1, Melisa Willby PhD1, Maureen Diaz PhD1 Development and Use of Quality Indicators to Strengthen Laboratory Quality Management Systems and Drive Continual Improvement. 1 Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA, 2 Tanaq Support Services, LLC.
Timeline
Quality Management Specialist
Tanaq Support Services / Karna, LLC, Atlanta, GA
06.2019 - Current
Quality Assurance Specialist
Omega Bioservices, Norcross, GA
01.2018 - 05.2019
Senior Laboratory Technician
Battelle Memorial Institute, Atlanta, GA
10.2012 - 04.2016
Medical Assistant
Family Medicine Specialists, P.C., Fayetteville, GA
02.2010 - 02.2012
Bachelor of Science - Biological Sciences (Human Biology)
Emory University
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