Shelby Nelson

Associate Principal Consultant

Shelby Nelson provides Quality Assurance (QA) and Chemistry, Manufacturing, and Controls (CMC) support to the pharmaceutical development and manufacturing industry.  Her primary expertise is in Quality Operations, overseeing quality control and manufacturing activities and ensuring compliance with current Good Manufacturing Practices (cGMP), cGMP compliance functions including internal, external, and regulatory audits and supplier qualification activities, and quality management systems (QMS). She has over 10 years of experience in the pharmaceutical industry and has previously held roles overseeing Quality Operations in small molecule Drug Substance, solid oral dosage Drug Product, and plasma-derived therapeutics manufacturing, supporting plasma fractionation, bulk processing, sterile filtration, inspection, packaging/labeling, and storage/distribution functions.  Shelby has a BS in Neurobiology and Physiology from Purdue University.