Quality Assurance Expertise of Deborah Parker

With nearly two decades of experience at the bench, Deborah Parker understands the mindset of scientists and quality assurance professionals alike. She has performed various bioanalytical services, including radioimmunoassays and enzyme inhibition assays, while conducting regulated bioanalysis using HPLC-UV, LC-MS/MS, and ELISA. Her transition into quality assurance has been significantly enhanced by her depth of understanding gained from laboratory experience. As a lead auditor, Deborah has been responsible for the qualification of over a dozen laboratories, both in toxicology and bioanalytical services, during her career, distinguishing between critical, major, minor, and non-relevant issues. 

Deborah has had the privilege of working for a top 5 pharma company, a leading CRO, and several small biotech companies. This varied experience allows her to understand the unique needs of each type of organization and adapt her audits accordingly. 

In her lab work, Deborah has analyzed both large and small molecules, becoming familiar with industry-standard software such as Watson, Analyst, SoftMax Pro, and various ELN platforms. As a former QA Manager, she reviewed software and equipment validation documents and participated in QMS evaluations. Deborah has also hosted unannounced regulatory inspections, including General GLP and directed inspections for clinical studies, as well as numerous client audits. 

In addition, Deborah was responsible for conducting and coordinating the development of GLP training programs, ensuring both annual refreshers and new hire training, as well as Inspection Readiness Training for her team. 

Deborah Parker holds a Bachelor's degree in Biology from Russell Sage College in Troy, NY, and an Associate's degree in Biotechnology/Environmental Health from SUNY Ag & Tech College, Cobleskill, NY. She is currently halfway through a Master's in Regulatory Affairs/Quality Assurance from Temple University, PA.