Director of Quality Assurance
As Director of Quality Assurance, Sara Nadeau is in charge of product safety. Playing a key role within the Edge team, she is charged with ensuring every dose that leaves the facility meets the stringent manufacturing and testing protocols. As an FDA registered and inspected 503B Outsourcing Facility, Edge must maintain a level of production care on par with traditional pharmaceutical manufacturers. This is very different from a compounding pharmacy, which is not required to provide either short or long-term potency and stability test data, nor maintain detailed batch records.
Working closely with both the production and science teams, Ms. Nadeau heads Edge's QA team, which has developed a comprehensive and rigorous methodology that includes advanced electronic record keeping and internal system audits rooted in the basic science at the heart of high quality pharmacology. The range of required QA tasks is very broad and includes potency testing for initial and extended time points, endotoxin validation of sterile injection products, ensuring media fills for process validations are performed, equipment calibrations and temperature mapping, certificate of analysis reviews, cleaning logs, and the monitoring of facility temperature, humidity, pressure, and pest control. In short, for product to ship, Ms. Nadeau must approve the doses. It is here that Edge differentiates itself from other companies. Edge customers know when they receive a medication it is done correctly every time.
Ms. Nadeau comes to Edge having previously worked as a microbiologist for a pharmaceutical laboratory. She has extensive experience in microbial testing, environmental monitoring, and water sample testing, having overseen teams investigating bioburden for filter sterilized products, environmental trend analysis, gram staining for microbial identification, and chlorine titration. Ms. Nadeau has a Bachelors in Biological Science from Long Beach, Mississippi.