Allison Cohen Email & Phone Number

Allison Cohen is a Biomedical Engineering Student at Thomas J. Watson College of Engineering and Applied Science, Binghamton University at Hanger Clinic. Colleagues describe them as "Allison (Alli) Cohen came to work for Mallinckrodt Pharmaceuticals (SpecGx) in Hobart NY as a summer intern in our Engineering Department before the start of her senior year of Biomedical Engineering. Our site provides approximately 6 billion dose of various schedule II DEA controlled drugs. I’m the Sr. Site Quality director and got to know Allison though her work on our USP (United States Pharmacopeia) water system. The USP water system is critical to our drug production and must function at the highest levels of water purity and sterility. A Total Organic Carbon (TOC) monitoring system is one of the key methods to show that the USP water is in a state of control. The data generated is used to make quality decisions that are reviewed by the Food & Drug Administration (FDA) during enforcement inspections. Due to recent health issues of microbial contamination of food and drug products the FDA has increased focus on potential sources of microbial contamination, of which water is considered a significant risk. The Hobart TOC monitoring system was at end of life with limited data analysis and capabilities. Its replacement was needed however projects like this create a risk to the site due to change and limited site resources. Alli’s main project during her internship was to implement a new Sievers M500 TOC monitoring system to greatly minimize these risks of potential microbial contamination. This was total lifecycle of change project that included: Communication with vendors, obtaining management appropriate equipment, Capital request process/approval, Purchase orders, change control, validation protocol, Installation, validation report and closeout of the change control. During this project Alli had to collaborate with the engineering, maintenance, and quality groups to finalize this project. These steps of the process required the understanding and use of multiple Mallinckrodt electronic systems including but not limited to Track Wise, DMS (electronic documentation), and the Computerized Maintenance Management System. Alli’s diligence and resilience was the reason this project was completed in a timely manner of less than 10 weeks during which she overcame several setbacks such as approval lags and access to electronic systems. Alli’s impact to the site was significant and her work cross functionally with other departments including my quality group was superb. Her completeness of the project had a significant impact to ensuring the manufacturing and quality of our drugs to meet the standards and regulatory requirements which ultimately leads to superior products for our patients. To finalize this project over the summer in approximately 2 months was a tremendous achievement.   Alli was a fantastic addition to our site as an intern and I hope when she finishes college that she would look to Mallinckrodt for a position in Engineering or perhaps Quality. I would enjoy having her on the Hobart team full-time."