Christopher Rush
President

M O R E . . .

Years of Experience: 15+
Founded FDAQRC in: 2009
Certifications: MBA

Chris inspected over 50 facilities including pharmaceutical and Bioresearch Monitoring (BIMO) inspections while working for FDA Chris was a member of the International Inspection Cadre and participated in six (6) inspections in Turkey, Bulgaria and Germany. He was presented with the US FDA Group Recognition Award, the US Food and Drug Administration Leveraging/Collaboration Award in May 2004 and the US FDA Outstanding Service Award in May 2006.

Chris took leave from the US FDA in 2007 and took his regulatory and inspection knowledge to a global IVD manufacturer where he worked as a Project Manager for Class II/III in vitro diagnostic (IVD) devices, his responsibilities included clinical trial monitoring, FDA submission and follow-up correspondence. Chris authored two (2) 510k applications that were cleared by the US FDA and assisted in the clearance of multiple other 510ks.

His experience transitioned well to a global pharmaceutical company where he conducted clinical QA audits, including routine and for cause audits that included all audit activities to assess compliance to established practices/standards and established regulations.

Steve Bliss
VP, Business Development

M O R E . . .

Years of Experience: 20+
Joined FDAQRC in: 2021
Certifications: MBA

Steve has a track record of proven success in creating mutually beneficial and profitable relationships with businesses, medical professionals, and consumers through multiple trade channels. His unique cross-industry experience includes life sciences, IT enterprise applications, business services, software, CPG-OTC and financial products and services.

Steve’s experience in working with small and mid-size companies is unique as he is exceptionally aware of their needs and the service, responsiveness, and consultation they require from a service provider to effectively support them.

Kara Harrison
Director of Operations

M O R E . . .

Years of Experience: 15+
Joined FDAQRC in: 2017
Certifications: RAC, RQAP-GCP

Kara joined FDAQRC as a Project Manager after working as a Consultant with us for many years. She is an experienced Clinical Research Professional with over 25 years’ experience in Clinical Research, QA, and Regulatory Compliance. Kara started her career as a Field Investigator with the US Food and Drug Administration, concentrating in BIMO program audits and inspections. Since leaving the agency she has had the opportunity to administer an IRB, and work in academia, big and small pharma, big and small CROs, and consulting. She has experience in most therapeutic areas for both drug and devices.

Michelle Copeland
Senior Project Manager

M O R E . . .

Years of Experience: 10+
Joined FDAQRC in: 2017
Certifications: RQAP-GLP/RQAP GCP

Michelle is a QA professional with over 10 years of GLP, Good Manufacturing Practices (GMP), GCP and International Organization for Standardization (ISO) experience in a wide range of clinical and pre-clinical studies. She conducted a wide range of audits with complex protocols including those with vulnerable populations. She has performed audits throughout North and South America including investigator site audits, vendor audits, for-cause audits and process audits.

She completed her Bachelor of Science in Biology at The Ohio State University. Michelle is a Registered QA Professional in Good Laboratory Practices (RQAP-GLP) and is an Active Member of the SQA.

Erich Zirzow
Senior Project Manager

M O R E . . .

Years of Experience: 20
Joined FDAQRC in: 2019
Certifications: MBA

Erich has worked in Clinical Research, Regulatory Affairs, and Quality Assurance. He has served as a Research Coordinator, Research Regulatory Specialist, Regulatory Compliance Manager, and Research Program Manager. His Regulatory and Quality Assurance experience includes conducting many internal, compliance, and investigative site audits.

Erich was fortunate to have worked on two of Cleveland Clinic’s largest groundbreaking clinical research studies that explored the genotypes that are responsible for premature coronary artery disease and heart attacks.

Tammy Lesko
Project Manager

M O R E . . .

Years of Experience: 20+
Joined FDAQRC in: 2018
Certifications: RQAP-GCP, MRQA

Tammy began her career more than 26 years ago in GMP manufacturing and transitioned to the US Food and Drug Administration as a Field Investigator with focus in GMP. At the FDA, she found her niche in GCP with BIMO inspections. After leaving the agency, Tammy’s primary focus has been GCP activities. She has provided GCP/Human Subject Protection, audit and inspection training presentations for several employers, clients, industry conferences and the Taiwanese FDA Investigators and Reviewers.

She has conducted hundreds of audits focusing on vendors (including CRO and IRBs), Investigator Sites, Trial Master File, Clinical Study Report, Due Diligence, and Inspection-related activities.

Tammy has a BS in Biological Science from Montclair State University.

Sarah Bronstad
Project Manager

M O R E . . .

Years of Experience: 10+
Joined FDAQRC in: 2020
Certifications: MBA, RQAP-GCP/GLP

Sarah is a QA professional with 15 years of GLP, GCP and ISO experience in both pre-clinical and clinical studies with a main focus in medical devices. She is a Registered Quality Assurance Professional (RQAP) in both Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) through the Society of Quality Assurance (SQA).

Sarah started her career as a histology technician working on pre-clinical medical device studies and then transitioned into a clinical research role at a gastroenterology practice.

She has a AAS in Histotechnology, a BS in Health Sciences and a MBA with a Healthcare Concentration.

Amy Wotawa
Project Manager 

M O R E . . .

Years of Experience: 10
Joined FDAQRC in: 2020
Certifications: MS

Amy is a Quality Assurance/Regulatory professional with over 10 years of experience in the biotechnology industry. She has a broad range of Quality Assurance/Regulatory Management experience from medical laboratory, pharmaceutical manufacturing, and food/dietary supplement manufacturing with expertise in improving products and facilities through driving regulatory compliance, quality assurance, policies, procedures, and projects. Amy has led multi-site, cross-functional teams through facility and product licenses, accreditations, certifications, internal and external audits, supplier quality management, project management, training development.

Camelia Kouki 
Lead Quality Auditor

M O R E . . .

Years of Experience: 20+
Joined FDAQRC in: 2017
Certifications: PhD, CCRP, RQAP-GLP, RQAP-GCP

Dr. Camelia Kouki is a QA and Regulatory Affairs (RA) professional with over 23 years’ experience in the research industry. Camelia began her career in cancer research where she spent five (5) years learning all the ins and outs of data management, drug management, laboratory and clinical processes. She then had an opportunity to work as a Clinical Research Associate (CRA) for a renowned cancer institute where she had the honor of working with cancer patients and their Oncologists to help them find the best research study that would aid in their treatment and quality of life.

Camelia’s QA experience became the center of her career once she joined a CRO to immerse herself in the US FDA regulations and ISO standards as she built the quality unit from the ground up supporting therapeutic areas such as multiple sclerosis, asthma, cancer, pediatric, autoimmune, liver, infectious and heart diseases. Camelia has managed GLP and CLIA laboratories and rounded out her GxP experience as a QA/RA Director for a start-up medical device company driving the process to achieve FDA 510(k) clearance and CE Mark for the medical device and ISO 13485:2016 certification.

Randall Morris 
Auditor

M O R E . . .

Years of Experience: 20+
Joined FDAQRC in: 2019
Certifications: MSN, CRM

Randall has worked  in clinical care, clinical research, conducting inspections/audits, and regulatory affairs. He has worked as a Clinical Nurse, Clinical Research Nurse, Clinical Research Coordinator, FDA Investigator, and FDA Compliance Officer and his experience includes conducting many FDA investigator site audits and review of numerous cases as a compliance officer. Randall began working with FDAQRC after working as a Compliance Officer with the US FDA.

Randall earned his Master of Science in Nursing-Clinical Research Management from Duke University  an undergraduate degree in Nursing from Old Dominion University.

Bonita Thomsen
Auditor

M O R E . . .

Years of Experience: 30+
Joined FDAQRC in: 2020
Certifications: RN, RQAP-GCP

Bonita has 30+ years of experience in both early and late phase clinical research. In addition to a background in critical care nursing, Bonita has a variety of experience in Quality Assurance – working in the Site Management Organization and academic environments, internal and emergency medicine research populations, and GCP auditing.

Bonita has been a part of many therapeutic audits, including but not limited to; Special Populations, Healthy Normal Volunteers, First in Man, General Cardiology, Cardiac Electrophysiology/Devices, Emergency Medicines, Infectious Diseases, Orphan Diseases, Drug Delivery Systems/Devices, Coagulation Disorders/Reversal Agents, Pulmonology, Endocrinology, Nephrology, Psychiatric, Neurology Biologics, Radiopharmaceuticals, Vaccines, Pediatrics, Anti-Venom, Dermatology, Podiatry, Controlled substances, nutritional products, and In-Vitro Fertilization.

Dawn Wydner
Auditor

M O R E . . .

Years of Experience: 10+
Joined FDAQRC in: 2017
Certifications: BSN, MS

Dawn has extensive U.S. Food and Drug Administration (FDA) Regulatory Compliance and Industry Quality and Compliance expertise. Dawn has been a sought out Subject Matter Expert with a proven track record of consistently establishing proactive compliance and application of quality oversight. She offers a firm grasp of all aspects of operational strategy, coordination and conduct of all Pharma R&D, Medical Device and Consumer markets; audit and compliance, safety and quality monitoring; and operational risk management across all GxPs. Dawn has more than 10 years’ experience as an US FDA Inspector, where she led and conducted Bioresearch Monitoring (BIMO) GCP and GLP inspections, Post Marketing Adverse Event Reporting (PV) inspections, drug and device GMP inspections assessing compliance with FDA regulations, Biologics inspections enforcing GCP, GLP, GMP, et al. Consultant is highly skilled in identifying non-compliance issues which resulted in several significant Regulatory outcomes.

Karen Andrews 
Resource Manager

M O R E . . .

Years of Experience: 15+
Joined FDAQRC in: 2018

Karen is a Quality Assurance Professional with more than 15 years’ experience in effectively managing the life cycle of audits. Experienced in tracking system support, producing, understanding and reporting metric data from multiple systems. Proven flexibility and proficiency in global customer support with experience in Quality System Management.

Janet Lee
Human Resources

M O R E . . .

Years of Experience: 10+
Joined FDAQRC in: 2016
Certifications: aPHR

Janet is a creative problem solver who enjoys connecting people with processes and resources which directly align with growth and development in a small company. Possess superior customer service and marketing skills with excellent written, verbal and interpersonal communication skills. Confident in the ability to make quick, calculated decisions and to think strategically in the moment. Flexible and resourceful with extensive experience in multi-tasking. Collaborates well within a team but thrives in self-directed positions by incorporating exceptional organizational skills and an acute attention to detail.

Janet has a Bachelors Degree in Speech Communications from Eastern Illinois University and a Master’s degree in Public Affairs Reporting from the University of Illinois at Springfield.

Kate Pfahl
Marketing 

M O R E . . .

Years of Experience: 5+
Joined FDAQRC in: 2020

Kate has a background in creative Marketing and has been an essential member of award-winning marketing teams. She has partnered with business development, sales, and operation teams to gain and maintain relationships with health providers, high-end retailers, lifestyle and entertainment brands. Kate manages our brand identity, social medias, and appearances at events.

Justin Clowers
Accounting 

M O R E . . .

Years of Experience: 10
Joined FDAQRC in: 2009

More details coming soon!

Jessie Aric 
Accounting

M O R E . . .

Years of Experience: 10
Joined FDAQRC in: 2018

More details coming soon!