The Quality Assurance (QA) team is a totally independent unit within product development. They ensure the safety, quality, identity, potency, and purity of the manufactured products is of the highest level. They ensure batch records are completed appropriately, all steps are adhered to, and that all release testing is done appropriately, ensuring the product is safe to be used in humans.
They assess vendors that supply raw materials and make sure manufacturers comply to standards and regulations, in order to ensure the product being received is of the highest quality.
The Quality Assurance team is part of the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. ORAQ supports the clinical research community at Duke University by offering regulatory and quality assurance support in all aspects of clinical research. Visit the link below to learn more about ORAQ.
At DHVI, the Quality Assurance team provides support to the Bioprocess Technical Manufacturing Operations (BTMO) team. The BTMO team has developed the capabilities to perform Master Cell Banking, Working Cell Bank Production, Mammalian Cell Culture, mRNA Production, Live Virus Product Manufacturing, Lipid Nanoparticle Encapsulation, and Fill Finish of products in house. The QA team supports these operations through a variety of activities including environmental monitoring and water for injection sampling. Click the link below to learn more about BTMO.
Team Building Activities
In order to foster a team environment, the Quality Assurance team schedules time outside of work to bond and serve the community. Check out a few of their activities below:
The QA team volunteered at the Food Bank of Central and Eastern North Carolina. The Durham Branch of the Food Bank serves 6 counties: Chatham, Durham, Granville, Orange, Person, and Vance.
In the 34 counties, the Food Bank serves 508,430 people live in food-insecure households, including 164,510 children. The Food Bank is working to provide more access to the healthiest food possible to the families they serve, and continuing to build solutions to reduce the existing meal gap. The QA team helped pack about 10,000 pounds of food to serve the local community.
The QA Team celebrates team accomplishments, birthdays, and work anniversaries each month. For major milestones, they have celebrated with fun activities such as a friendly golf competition at Drive Shack in Raleigh.