Responsible for coordinating and executing Biotest Pharmaceuticals' lookback program and post donation reports to customers and Boca plant. Coordinate communications between State, CLIA and COLA programs with Center Management. Contribute to compliance with FDA's requirements for Biological Product Deviation Reporting. Assist in preparation of EPI reports for customers, authorities and PPTA.
Familiarity with Plasma Center operations and processes as well as FDA and state license requirements in the plasma industry. PC literate with advanced knowledge of software programs such as Word, Excel, SAP and Outlook. Excellent organizational skills, critical/analytical thinking, ability to prioritize, attention to detail and accurate typing a must; technical writing skills; good customer service skills and strong decision making skills.