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The Quality Assurance Analyst performs and evaluates various studies for the purpose of improving procedures in the Operational environment. The Analyst is also responsible for production and administration of the internal proficiency testing program for more than sixty diagnostic laboratories. This position is additionally responsible for establishing and implementing an in-house calibration program for all pipettes and centrifuges.
Job Responsibility:
Lead data analysis and evaluation for cross-project studies focused on driving operational improvements in laboratory environments
Manufacture proficiency samples comprised of mixed sample pools utilizing good judgement to ensure analyte concentrations are within analytical measurement ranges for the species utilized
Evaluate analyte concentrations and determine the necessity to adjust through dilution or additive addition to establish meaningful concentrations
Establish lyophilization processes for multi-matrix sublimation through studies to ensure specimen viability upon reconstitution, post lyophilization
Maintaining web-based result entry platform, ensuring appropriate modules are in place for quarterly result submission
Evaluate results of proficiency testing and determine acceptability based on total allowable error limits established through such organizations as ASVCP and CLIA
Compile data and report findings of proficiency submissions to the participating laboratories and QA Specialists
Perform statistical analysis to report to the quality assurance director along with bi-monthly production/status reports
Establish a pipette calibration schedule to be applied company-wide, and perform all pipette calibrations to ensure they perform within manufacturer specifications
Troubleshoot out-of-specification pipettes and perform any necessary repairs or adjustments to return pipettes to within compliant performance specifications
Support other initiatives of the quality assurance department in measuring and maintaining quality standards at the discretion of the quality assurance director
Performs other duties as assigned
Requirements:
BA/BS in life science or other applicable field
Minimum two years of bench tech or 2 years of veterinary lab experience desired
Working knowledge and understanding of current Good Lab practices in diagnostic lab industry
Flexible, Innovative, Team player, Committed, Should be a self-starter and Result-oriented
Personal Computer literate
Analytical skills pertaining to scientific and laboratory activities
Good verbal and written communication skills
Know how to accurately record and evaluate data using statistics software