Danielle E. Downs

Ms. Downs provides an array of quality assurance and regulatory services to SciReg’s clients. She has experience as a quality assurance auditor in Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations and also assists our clients with product registrations, including label development, study placement/monitoring, study protocol/report reviews, and dossier compilation.

Before joining the SciReg team, Ms. Downs was a Senior Quality Assurance Specialist at Microbac Laboratories, Inc. In that role, she was responsible for all aspects of the laboratory’s cGMP/GCP/GLP quality program such as in-process inspections, protocol reviews, final study report reviews, and raw data reviews. She was head of document control and helped develop their GMP document control procedures, as well as helping to incorporate risk-based thinking.

Ms. Downs earned her bachelor of science degree in Biology with a concentration in Environmental and Conservation Biology at George Mason University. She is an active member of the Society of Quality Assurance (SQA) and National Capital Area Regional Society of Quality Assurance (NCARSQA). Ms. Downs is also certified as a Registered Quality Assurance Professional in GLPs (RQAP-GLP).