As the Regulatory Affairs/Safety Specialist, Ana is in charge of keeping Genesis Biosciences compliant and safe. Her years of experience with the FDA makes her the perfect fit for the job.
Here at Genesis Biosciences, Ana Kewes is involved in managing regulatory strategies, preparing us for all US and international regulatory submissions and keeping the company safe by coordinating our safety practices.
Before joining the Genesis team, Ana spent 16 years working for the Food and Drug Administration (FDA) where she conducted inspections and determined regulatory compliance. Prior to this she worked as a Project Manager with the US Army Corps of Engineers, where she oversaw the environmental remediation of formerly used defense sites.
Her extensive experience with state and federal agencies – such as the FFA, FEMA, FDA and HUD – and their regulations helps ensure that Genesis is fully compliant with important industry standards.
But how does Ana’s many years of regulatory experience contribute to her day-to-day work at Genesis? We asked Ana herself…
Some people probably wouldn’t know what your role involves – how would you explain it?
As the Regulatory Affairs/Safety Specialist I’m tasked with bringing Genesis Biosciences up to the Food Safety Modernization Act (FSMA) regulatory compliance, since we are a manufacturer of the active ingredient in probiotic dietary supplements for human and animal consumption. This is the direction Genesis is going in the near future and I’m excited to be a part of that future.
What was it about Genesis that made you want to work here?
Ever since I saw the job announcement and description, I knew it was something I would want to do as it involved Regulatory Affairs as well as Health and Safety.
My experience includes 16 years as an investigator at the Food and Drug Administration (FDA), as well as previous positions in Industrial Hygiene. These roles have provided me with a unique set of skills that I’m putting to use at Genesis Biosciences, so that I can contribute to the continuing improvement of employee and consumer health and safety, as well as FDA regulation.
I have always thought that I would never be able to use my complete set of skills in one job due to the fact that they are very diverse. When I found out more about this job, however, I felt it was made for me.
What’s one thing that drives you in your work?
This job is not only interesting, but also very diverse. I love that I get to learn something new every day! Recently I’ve been developing my understanding of the fermentation process and its complexities – I can’t wait to learn more.
What’s the best thing about working at Genesis?
The loyal and hard working individuals that make Genesis their work family!
What does your typical day include?
A typical day for me could include working on the Food Safety Plan or Hazard Analysis and Critical Control Point (HACCP), reading and writing standard operating procedures (SOP) and working with our management team to come up with solutions to our fermentation challenges.
What’s your personal philosophy, if you have one?
I take my job personally and I see it as a reflection of myself, so I do my best to be proud of the work I do every day.
What is one thing the general public might not know about your job?
Due to the nature of my job I’m involved with all the departments here. Including but not limited to: fermentation, maintenance, laboratory services and purchasing.
What would you say is your / Genesis’ greatest achievement so far?
I think we have accomplished a great many things since my arrival here regarding FSMA compliance. I expect we will accomplish even more in the months to come.
What’s next for you at Genesis?
I need to make sure our firm is ready for an FDA inspection at any time.
To find out more about the work of Ana and Genesis Biosciences, take our tour.
If you liked this article, read a few more recent ones below: