Novella Clinical, Inc. - Durham, NC since May 2012
Quality Systems Associate
NorthStar Research Institute, LLC - Cary, NC Jan 2009 - Apr 2012
GCP Quality Assurance Auditor
Durham County Public Health Department - Durham, NC Aug 2010 - May 2011
Public Health Graduate Intern- Part time
North Carolina Central University - Durham, NC Aug 2009 - Jun 2010
Graduate Research Assistant – Part time
Talecris Oct 2008 - Jan 2009
Sr. Quality Associate I, R&D Documentation and Records
Skills:
Fda Gcp Clinical Trials Pharmaceutical Industry 21 Cfr Part 11 Quality Assurance Clinical Development Capa Medical Devices Biotechnology Ctms Quality Auditing Glp Clinical Monitoring Regulatory Requirements Irb Public Health Sop Development Risk Assessment Regulatory Submissions Gdp Mhra Pmf International Travel Data Management Quality Management Sharepoint Iso Corrective Actions Risk Management Public Policy Isf Documentum Clinical Site Monitoring Clinical Site Management Clinical Research Process Vendor Qualifcation Audits Root Cause Analysis Inform 5.0 Edms Full Scope Audits Audit Planning General Audit Matrixs Rave Study Monitoring Investigational Product Reconciliation Medical Monitoring Compliance Audits Process Audits Argus Safety