Consulting as a GLP expert, in the QA and study report functions as well as FDA 483 remediation activities.
WuXi AppTec | St Paul, MN, USA
April 2016 - June 2019
Rebuilt a group of study directors who specialized in custom study designs and protocols. Functioned as study director when needed. Designed custom studies to satisfy FDA, ISO, and/or customer needs
GLP and GMP consultant
Quackenbush Consulting | Erie, CO, USA
March 2010 - March 2017
1. QA DIrector for 2 contract research facilities that received USA FDA GLP Warning Letters and hosted the FDA inspection to close out the Warning Letters.
2. Worked with US and international clients to troubleshoot and improve product release test methods, develop Quality Policies and SOP, and serve as facility QA unit.
Doctorate / PhD, Microbiology/Immunology | Buffalo, NY, USA
Masters, Microbiology/Immunology | Buffalo, NY, USA