SCIENTIST SPOTLIGHT: June 2017

Name: Rebecca Forster
Alcami Site: Charleston, SC

How long have you been with Alcami?
I have been with Alcami for 2 ½ years.

What is your role?
I am the team lead for the Microbiology Department at the Alcami Charleston, SC facility.

Our team is responsible for microbiological monitoring of the environment that is involved in the manufacturing of parenteral drugs. The team also tests the product, performs utility testing, personnel monitoring and aseptic gowning training, sterilization cycle validation support, media fill support, and method suitability testing (just to name a few!) for added assurance that the product is sterile. 

What is the most rewarding part of your job?
Microbiology testing lies at the very heart of parenteral manufacturing. Knowing that what I do helps patients have a safe and effective product that has potential to save and/or change the quality of their lives is incredibly rewarding. There are not a lot of careers that offer the ability to have that type of impact.  Solving challenges such as leading investigations, as well as working on continuous improvement, is always a welcomed part of my day.

We introduced Lean Six Sigma training at the operator level to take Six Sigma principles to the floor, which has increased organization and optimized testing capability. We also recently added 24-hour environmental monitoring support for the facility after 3^rd shift production was implemented in support of business needs. Additionally, we upgraded our procedure and software for electronic reporting of utility testing and environmental monitoring as a means of staying current with the "c" in cGMP.

How do you see those accomplishments affecting the pharmaceutical industry?
Our recently implemented process improvements have developed talent, and made our department more efficient and poised to be successful in the dynamic environment of a CDMO. With microbiological testing being such a critical aspect of our process, it is essential to always remain up-to-date with the ever-changing technology and knowledge base of this industry.

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