Operations/Investigations Specialist at Takeda PharmaceuticalsResponsibilities/Accomplishments: -Execute root cause analysis for manufacturing deviations and execute investigation records within record management systems to track investigation progress to meet product fulfillment dates. -Accountable for timely documentation of comprehensive investigations related to in-process product monitoring, critical systems monitoring, out of level/out of specification results, and personnel monitoring. -Write and manage deviation reports (Investigation Reports, CAPA records, OOXs) under the direction of Compliance Management. -Facilitate cross-department partnerships, including collaboration with Quality Assurance team members to ensure FDA regulatory compliance. -Lead problem solving events, including leading investigation closures of manufacturing compliance related documents. -Use quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance. -Identify and implement process improvement and Value Improvement Projects (VIP) to drive success in the areas of compliance, throughput, workplace safety, cost effectiveness, and product lead time.

Undergraduate Research Assistant in the Blazeck Immunological and Cellular Engineering LaboratoryResponsibilities/Accomplishments:-Contributed to research in the Blazeck Immunological and Cellular Engineering Lab, supporting PhD candidate Andrew Kristof. -Research goal was to examine DNA regulatory elements and their effects on the expression of distant genes based on chromatin conformations and apply this to regulate genetic expression within cancer cells.

Process engineering intern for Italmatch USA CorporationResponsibilities/Accomplishments: -Researched methods to remove contaminant chloromethane from wastewater streams and tested pilot air stripping technology to remove chloromethane from wastewater, per EPA regulations. -Synthesized data from pilot tests and performed calculations to develop a full-scale process for plant-wide implementation. -Developed the scope needed to implement the use of 50% Caustic Soda in the plant via storage tanks and the addition of automation to reactors. -Performed cost estimates on piping and needed equipment, developed P&ID’s and plot plans, and analyzed Caustic Soda use in batches. -Worked with EHS personnel to move flammable liquid storage to a more safe and secure location, ensuring that the new space was compliant with all OSHA and DOT requirements. Utilized a plot plan of the plant to select potential storage sites, then examined sites to ensure compliance prior to selecting a final location. -Employed PLC data to reduce batch times and suggest the implementation of automation in highly manual processes.