I have 8 years of quality experience in various GMP production environments. Some of my qualifications include:• Six Sigma DMAIC Orange Belt Certified - demonstrating investigational problem solving skills• Strong technical writing skill authoring SOPs and reports (deviations, CAPAs, change controls, etc.)• Proficient with Quality Management Systems: LabVantage, Trackwise, Veeva, QLIMS, M-ERP and LIMs Darwin• Experience with ISO 5, 7 and 8 environments using aseptic technique/sample handling, instrument sterilization, Cell based assays, analytical testing and Environmental Monitoring (EM)• Knowledge of various requirements: GDP, cGMP, GLP as well as FDA CFR regulations