Carla Gibbons

Carla has 30 years of experience in the pharmaceutical and biotechnology industry.  She has extensive experience in Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) FDA regulations and ICH guidelines with regard to analytical testing, batch testing and quality assurance while at GlaxoSmithKline.  In her previous position as President of her own QA consulting company, she provided FDA GLP, cGMP and GCP quality assurance services, such as performing vendor audits, writing, editing and reviewing SOPs and reviewing GLP, GMP and GCP data and reports for pharmaceutical and biotechnology clients.

Since being at BioAgilytix, Carla has been responsible for managing the Archives, auditing regulated study data and reports, auditing validation and IQ/OQ/PQ protocols, tests and reports, auditing deviations, investigations and CAPAs, performing phase, process, and facility audits.  She is also responsible for writing and reviewing SOPs, updating and maintaining the Master Schedule, and managing the scheduling of all data audits and inspections.  Carla has a BS degree in Biology and a BA degree in chemistry from Meredith College and has taken multiple graduate classes in analytical chemistry at North Carolina State University.