Quality Assurance Team

 

Duke Human Vaccine Institute (DHVI) cGMP Program

 

Elizabeth Bailey
Quality Assurance Associate

Email: elizabeth.bailey@duke.edu
Phone: (919) 681-2945

Elizabeth Bailey is a Quality Assurance Associate in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, she is responsible for performing a variety of Quality Assurance duties to ensure compliance with applicable regulatory requirements and for providing Quality oversight for activities supporting the Duke Human Vaccine Institute cGMP Program.

Elizabeth received her undergraduate degree in Pharmaceutical Science from Campbell University. She brings quality assurance and quality control experience in both clinical and commercial GMP drug substance manufacturing.

 

​Lieza Capiz
Quality Assurance Associate

Email: lieza.capiz@duke.edu
Phone: (919) 613-8578

Lieza Capiz is a Quality Assurance Associate in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, she is responsible for performing a variety of Quality Assurance duties to ensure compliance with applicable regulatory requirements and for providing Quality oversight for activities supporting the Duke Human Vaccine Institute CGMP Program.

Lieza received her undergraduate degree from Campbell University. She brings 10 years of combined clinical, facility start-up and commercial experience in support of sterile, biological, autologous cell therapy and Immunology products.

 

Molecular Products and Cell Therapy (MPACT)

 

Lauren Lombardo 
Quality Assurance Associate

Email: lauren.lombardo@duke.edu
Phone: (919) 668-9357

Lauren is a Quality Assurance Associate within the Duke University School of Medicine Office of Regulatory Affairs and Quality. She assists the Molecular Products and Cell Therapy (MPACT) facility in developing and maintaining current Good Manufacturing Practice (cGMP) compliant systems (Standard Operating Procedures; SOPs), training, facilities, equipment, process, and test methods appropriate for the phase of clinical development. As a Quality Assurance Associated in MPACT, Lauren is critically involved with review of batch records and approval of Certificates of Analysis for release of any clinical material.

She received her undergraduate degree from the University of South Carolina Aiken and brings experience in quality systems from commercial cGMP drug manufacturing.

 

Marcus Center for Cellular Cures (MC3)

 

Betsy Jordan
MasterControl System Administrator

Email: betsy.jordan@duke.edu
Phone: (919) 668-7091

Betsy Jordan is the MasterControl System Administrator within the Duke University School of Medicine.  Her role is to support document management through the design, deployment, and maintenance of the electronic document management system (EDMS), MasterControl.  Betsy brings many years of considerable expertise from the pharmaceutical/biotech industry from positions involving document management, regulatory affairs, records management, and administrative support services.

Prior to joining Duke, Betsy was the Document Control Manager at AlphaVax responsible for MasterControl and all related document management activities.  Her expertise has evolved along a career path that includes Burroughs Wellcome Co., Quintiles, Triangle Pharmaceuticals, and AlphaVax.  Betsy received an Associate Degree from Hardbarger Business College and is a graduate of the Burroughs Wellcome Management Institute at UNC.

 

Bing Shen, MD, PhD
Quality Assurance Associate

Email: bing.shen@duke.edu
Phone: (919) 668-5474

Bing Shen, MD, PhD is a Quality Assurance Associate in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, she is responsible for ensuring that the products meet the quality requirements for their intended use and that the quality systems are maintained and enhanced compliance to the standards set forth by the regulatory and accreditation agencies. She performs a variety of quality related tasks with a focus on supporting the Marcus Center for Cellular Cures (MC3) at Duke University.

Dr. Shen is a foreign Medical Graduate. Following her work as a Resident in the Division of Cardiovascular Medicine in China, she conducted her graduate research at Tulane University, where she earned her PhD in Physiology. Her research focused on the cross-talk of the renin-angiotensin and kallikrein-kinin systems. During her graduate training, she was the recipient of an American Heart Association Predoctoral Fellowship and a Research Recognition Award at the 2005 Experimental Biology (EB) & International Congress of Physiological Sciences meetings. After her graduate studies, she accepted a position with the Department of Medicine within the Duke University School of Medicine as a Postdoctoral Research Associate studying the role of Wnt signaling in the heart regeneration following myocardial infarction. She holds the certification from the Educational Commission for Foreign Medical Graduates (ECFMG).

 

Colleen McKoy
Document Control Specialist

Email: colleen.mckoy@duke.edu
Phone: (919) 668-0740

Colleen Mckoy is a Document Control Specialist serving on the Quality Assurance team for the Office of Regulatory Affairs and Quality.  She assists the MasterControl System Administrator with responsibilities in monitoring the lifecycle of documentation and assisting team members in related tasks and inquiries.  Prior to joining Duke, Colleen worked as a senior documentation specialist for Talecris Biotherapeutics, Grifols, and Hospira bringing 7+ years’ experience in the area of quality documentation.

Colleen attended Appalachian State University in Boone, NC, graduating with a Bachelor of Science in Psychology; and she has an Associate degree in Applied Science in Chemical Technology from Cape Fear Community College in Wilmington, NC.
 

Isabel Storch, PhD
Quality Assurance Associate

Email: isabel.storch@duke.edu
Phone: (919) 668-6044

Isabel Storch is a Quality Assurance Associate at the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In her role, she provides QA support to the Stem Cell Transplant Lab, as well as other programs at the Marcus Center for Cellular Cures (MC3). The Stem Cells Lab provides laboratory support for cell therapy applications for clinical use and clinical trials. 

Dr. Storch obtained her PhD in Organic Chemistry developing novel methods to synthesize glycosidase inhibitors. She later worked as a Validation Specialist for Merck &            Co.’s manufacturing division, providing support in Quality Assurance and cGMP compliance at a solid dosage manufacturing site in Alcala de Henares, Spain.
 

Lisa Eddinger
Quality Assurance Associate

Email: lisa.eddinger@duke.edu
Phone: (919) 668-8594

Lisa Eddinger is a Quality Assurance Associate in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, she is responsible for ensuring that the products meet the quality requirements for their intended use and that the quality systems are maintained and enhanced compliance to the standards set forth by the regulatory and accreditation agencies. She performs a variety of quality related tasks with a focus on supporting the Marcus Center for Cellular Cures (MC3) at Duke University.

Lisa received her undergraduate degree in biology from North Carolina State University and then worked as a research associate in the Immunology and Virology Lab at the NC State School of Veterinary Medicine.  Prior to joining QRAQ, Lisa gained experience across various regulated industries working as a molecular genetics technician at LabCorp, Pre-Analytical Manager at EA Genomics, and Supervisor of the Carolinas Cord Blood Bank (CCBB) Processing Lab within the Marcus Center for Cellular Cures (MC3) at Duke University.

 

Richard Bryant
Quality Assurance Associate

Email: richard.bryant@duke.edu
Phone: (919) 681-8862

Richard Bryant is a Quality Associate within the Duke University School of Medicine for the Marcus Center for Cellular Cures (MC3).  In this role, Richard is responsible for providing cGMP quality assurance support and guidance to manufacturing and research staff.

Richard received his undergraduate degree in biology from Virginia Polytechnic Institute and State University.  He has more than 15 years quality experience across  multiple GXP regulated industries. His key areas of expertise include cGMP manufacturing and quality process management.

 

Taylor Orr
Quality Assurance Associate

Email: taylor.orr@duke.edu
Phone: (919) 668-1088

Taylor Orr is a Quality Assurance Associate at the Office of Regulatory Affairs and Quality within the Duke University School of Medicine. In his role, he provides QA support for work being conducted in the GMP Facility at the Marcus Center for Cellular Cures. The GMP Facility is one of several labs within the Marcus Center that processes allogeneic and autologous tissue for use in clinical trials at the Duke University Medical Center.

Taylor began his career in a plant pathology lab at Texas A&M University, studying the innate immune response of plants to bacterial infection. After completion of his undergraduate training, he entered the pharmacology graduate program at Duke University. While the bulk of his academic research focused on endothelial signaling and homeostasis, he also contributed to the characterization of investigatory small molecule compounds in various pathologies related to vascular breakdown and inflammation. While working alongside clinicians in laboratories at the medical center, Taylor quickly developed an appreciation for drug development and an understanding of the need for safe and effective therapeutics.