Quality Control Lead
Current● Product Stability: Protocols, reports, trend analysis of HIV/HCV Microbial and Antigen product stability ● Data Audit: Review Microbial/Antigen testing results, Method Development validation data, executed Installation, Operation, & Performance Qualification (IOPQ) protocols● Document Management: Write and edit IOPQ protocols, Qualification Summary Reports (QSR), Stability protocols and reports. Edit and process Standard Operating Procedures (SOPs) for Quality Control Analytical, Microbiology, and Raw Materials groups● Database Management: Documents, Laboratory and manufacturing equipment inventory, Stability time-points (30+ years), Long-term off-site data storage● Key Performance Indicators (KPIs): Track and trend laboratory testing and equipment deviations, ● Change Control: Develop strategies, Deploy change control actions● Equipment Management: Onboard, qualify, decommission laboratory and manufacturing equipment