Q&A with Donna Callery, Director of Quality Assurance

Who are you?

My name is Donna Callery and I am the new Director of Quality Assurance at Oligo Factory.  I have 25 years of experience in the Medical Device/Pharmaceutical industry managing cGMP and ISO13485 Quality Systems.  I’m thrilled to have the opportunity to work with the incredible team at Oligo Factory to ensure we produce some of the highest quality oligos available.

What will you be doing in your new role?

I will lead the Oligo Factory team in the implementation of an ISO13485 QMS as well as a cGMP ICH Q7 compliant manufacturing site. This will increase our level of product reproducibility, traceability and overall continuous improvement.  It’s an investment that is extremely beneficial to us as well as our customers.

What excites you about working at Oligo Factory?

I’m excited to be part of a team with many years of chemistry experience that has fresh energy, motivation, and enthusiasm for the products they produce. I’m also excited to help them take the next step to align with GMP standards.

What do you love about working in biotech?

I love being part of a company that contributes to innovative research and development for the medical device and pharmaceutical fields.  It makes me feel like I am part of something bigger that saves lives and improves quality of life around the world.  Personally, it’s a perfect fit to be able to apply my scientific background while doing something that I love. 

What are you and the rest of the team hoping to achieve?

We are looking forward to achieving our ISO13485 certification along with cGMP ICH Q7 compliant manufacturing site by the end of 2023.  Our goal is to grow our business while ensuring we meet the product quality and reliability expectations that our customers require and deserve. Our future is bright.