Post-Doctoral Fellow, Quality Assurance Fellow
CurrentSupport and participate in GxP activitiesDevelop tools for tracking key performance indicators, create charting of KPI metrics, and collect KPI data from records and the QA team.Track status and progress of the Annual Audit Schedule ensuring that audit deliverables are completed in a timely manner.Ensure accurate filing of GxP audit records, investigation reports, associated corrective and preventive actions (CAPAs), and deviations.Assist in GxP Inspection Readiness Activities including the tracking and scheduling of Story Board development and reviews.Work with QA team to identify enhancements to Vendor tracker, ApprovedVendor List, and other tracking tools.Assist Document Control with formatting, preparation, and review of controlled procedures within the EDMS.Work collaboratively with the QA team to identify business processes and areas that require improvement and implement appropriate methods and tools to increase efficiencies.Support EDMS System Administrator with user testing of system configuration changes.