INTERVIEW QUESTIONS
Rich O'Donnell
Senior Quality Systems Manager
Steris Corporation
1. What is your
job title?
Senior Quality Systems Manager
2. What are your job responsibilities?
I make sure that my site
is following the FDA and ISO regulations with regard to the manufacturing
of medical devices. We make biological indicators to monitor sterilization
processes.
3. What is your background? (education and training)
I received a Bachelors degree in comprehensive
Biology at John Carroll University and have a Masters degree in Biology/Microbiology
from
the University of Dayton. I’ve been in Pharmaceuticals and
Medical Devices under current Good Manufacturing Practices (cGMP’s)
for about 20 years.
4. Where are you employed?
STERIS Corporation-Pinecone
Biological Operations
Can you tell me something about the company you work for?
STERIS Corporation is a great place to work. We are committed to
making the world a better place and are on the forefront of contamination
and infection prevention.
5. What is a typical day at work like for
you?
A typical day involves answering numerous phone
calls and e-mails pertaining to Quality
of our products and processes. I attend about 3-6 meetings per day
and travel about 6-10 times per year on business. About 75% of my
day is planned while 25% involves addressing pressing concerns that
come up on the spur of the moment. A lot of decisions need to be
made and therefore a lot of data and information needs to be reviewed.
I’m currently on 6 AAMI (Association for the Advancement of
Medical Instrumentation) standard committees that meet in Washington
DC twice per year to develop sterilization standards.
6. Can you tell me about
any particular projects that you are currently working on?
I’m not at liberty to
discuss new projects but can state that we are continually looking
at improving current processes
and evaluating newly developing technologies. Any company that does
not do this is risking being out-competed by the competition.
7. What general work skills do you use on a daily basis?
We need
to understand how our processes and products work. The biological
indicators we make require a strong understanding of microbiology
and some chemistry and engineering skills to optimize efficiency
and quality in their manufacture.
8. What advice do you have for someone who wants to pursue a career
in biotechnology?
I would say that you need to keep up with the current
technology. Never rest on your laurels! As soon as you think you
are caught up on all aspects of Biotech you are wrong. The industry
is evolving as we speak and it takes a strong, vigilant person
with educational discipline to keep up. Read as many sources as you
can
to keep abreast of what is going on. Magazines, journals, TV, newspapers,
internet, classes, etc. all help to keep current, but it will be
in your best interest to attack them aggressively. Once you stop
it will be hard to catch up with the best out there.
9. Where do you see opportunities in Biotechnology
in the next 5-10 years in Northeast Ohio?
I
think the coordination of efforts with University Hospitals, The
Cleveland Clinic and Case Western Reserve University
will bear much
fruit in the future. The academic environment locally is top-notch
and we have numerous start-up companies that are just about ready
to break out of their shell. We are at a point where we in the
Cleveland area can emerge as one of the world leaders in
biotechnology if the
resources continue to grow at the pace they are now. The ideas
are there and they are just beginning to take shape. The
students at
Lakeland will be on the forefront of this advancement and can say
they are the foundation on which this biotechnology boom will be
built.
