Sr Quality Assurance Specialist
Oversee over 100 different new method validations. Conduct monthly quality meetings to review key performance indicators. Manage document control. Perform root cause analysis for quality deficiencies. Create and edit standard operating procedures. Perform internal audits and host external audits. Obtain and maintain accreditation with CAP, CLIA, COLA, and ISO. Perform Measurement of Uncertainty for entire laboratory.• Key performance indicators• Management• LDT and FDA Approved validations • GLP/GMP Experience• CAP, CLIA, COLA, and ISO regulations• Root Cause Analysis