Data Associate
CurrentKite Pharma is a subsidiary of Gilead Science that develops cancer immunotherapy products focused on engineering a body’s T cells to fight forms of leukemia and lymphoma.• Verify and analyze data from patient manufacturing records using Excel spreadsheetso Investigate statistical trends for In Process Controls (IPCs)• Compose quarterly Process Monitoring Reports (PMR) for US Commercial lots during Quarter 2 and 3 of 2019o Use JMP Pro 13 predictive analytics software to create control charts for each In Process Control (IPC) and SQL queries to retrieve datao Create an appendices document for all data referenced in report using Excel• Participate in regulatory agency inspections and audits: Food and Drug Administration (US FDA), Therapeutic Goods Administration (Australia) , European Medicines Agency (EU)o Compile confidential documents and collecting Subject Matter Experts (SME’s) for strategizing presentationso Transport confidential documents between the preparation and inspection rooms as requested by inspectors