I've found a new home in Round Rock, TX. Pro-Lab Diagnostics is an exciting new adventure for me, offering an opportunity to explore an entirely different area of molecular medicine. I've worked in a number of labs which utilize IVD kits; this is the first time I've been able to see how these kits are not only produced, but to witness and be part of the thought process that goes in to the design of them. As a IVD manufacturer we will work with the FDA to get assays and products to market, and as a CLIA lab we will work to offer our assays to clinics and clinicians. Exciting days ahead!

This had the bones of a good thing. The science worked wonderfully - adapting molecular methodologies to the veterinary workspace. Unfortunately the timing was not right relative to the market.

Essential Job Functions:• Monitor production volume and flow within the lab and delegate responsibilities appropriately.• Troubleshoots any assay or instrument issues that may arise in clinical workflow.• Monitor lab TAT. Ensure that all samples processed in the lab are pushed through to the downstream queues in a timely manner. • Be the go to person for inquiries regarding laboratory quality issues. Investigate inquiries regarding lab QC issues and performing appropriate corrective actions. Ensures patient test results are not reported until all corrective action has been taken and the test system is functioning properly• Reviewing and signing off on all laboratory documentation• Ensure that maintenance (routine PM’s and error related) is scheduled when appropriate and carried out by the manufacturing technician. Make sure that all follow up activities are performed • Perform all instrument calibrations as scheduled and document all practices. • Perform all semi-annual parallel runs (between instruments and between platforms) as scheduled. • Monitor reagent and supply stocks and submit orders to purchasing coordinator when needed.• Respond to technical inquiries from technologists regarding assays per SOP. Must make judgment calls when needed.• Documentation of failed runs (incident reports)• Train all technologists on new assays. Oversee qualification. Fill out qualification paperwork• Perform competency evaluations of all techs on qualified assays as scheduled.• Perform assay validations; write SOP’s, and validation reports.• Work with IT to get workflow into LIMS system• Assist IT and technologists with system errors, workflow issues, workflow modifications etc in the laboratory process. • Review of all laboratory SOP’s quarterly. Update of SOP’s when needed.• Ensure the laboratory stays clean and organized. Assign duties to other technologists where appropriate. • Other duties as assigned by the Lab Director

Responsible for the intake and accessioning of all cytology and molecular samplesResponsible for sample bar coding and demographicsProcessed ~4,500 clinical samplesHologic ThinPrep 5000 OperatorSakura Tissue-Tek Prisma/Tissue-Tek Film OperatorHologic ThinPrep Imager Duo OperatorHologic Panther Key OperatorResponsible for sample storage and disposalGeneral lab maintenance and quality controlDeveloped, validated and launched an in-house quantitative assay (LDT) for BV/CVDesigned and developed analysis software for use with BV/CV LDT

» Responsible for Sanger sequencing analysis of more than 100 tests» Managed sample tracking and test turn-around times» Worked with a wonderful team of seven to eight within the Sanger Core, and a greater group of nearly twenty technicians and technologists» Reported test results on a daily basis to a group of ten certified Directors» Participated in Kaizen, 5S, QA/QC, and Lab Juku projects» Participated in CAP/CLIA and NY State laboratory inspections, as well as others ordered by providers and suppliers» Assisted in the automation of the data management and project compilation portions of my job

PyroSequencingPCRRT-PCRSanger SequencingSequencing Analysis