Responsibilities and Accomplishments:Transfer of manufacturing procedures for molecular diagnostic assay from Assay Development to OperationsProcurement of critical raw materials for molecular diagnostic assay during Technology TransferExecuted the production and delivery of PCR kits for clinical Alpha and Beta studiesExecuted new supplier qualification of critical raw material for prostate PCR assayCreated and implemented new Design History File documents during Technology… Show more Responsibilities and Accomplishments:Transfer of manufacturing procedures for molecular diagnostic assay from Assay Development to OperationsProcurement of critical raw materials for molecular diagnostic assay during Technology TransferExecuted the production and delivery of PCR kits for clinical Alpha and Beta studiesExecuted new supplier qualification of critical raw material for prostate PCR assayCreated and implemented new Design History File documents during Technology TransferCreated Bill of Materials and Master Recipes for existing IVD product for new ERP systemProcess validation of current manufacturing processes in new facilityCreated and implemented material control SOP for VeridexKnowledge of change control management and Corrective/Preventive Actions Training new operators on manufacturing procedures, department standard operating procedures, and raw material specifications Show less

Experience with reverse transcriptase-polymerase chain reaction assayRevised manufacturing batch records and standard operating procedures through change control process for continuous improvementFormulation of bulk reagents for GeneSearchTM IVD productPerform operations as described by standard operating procedures under GMPDrafted protocols and summary reports for IQ/OQ/PQ of manufacturing equipmentMaintain equipment in proper working orderProperly complete… Show more Experience with reverse transcriptase-polymerase chain reaction assayRevised manufacturing batch records and standard operating procedures through change control process for continuous improvementFormulation of bulk reagents for GeneSearchTM IVD productPerform operations as described by standard operating procedures under GMPDrafted protocols and summary reports for IQ/OQ/PQ of manufacturing equipmentMaintain equipment in proper working orderProperly complete manufacturing documentation, operate machineryConduct basic quality inspection of work in accordance with statisticalprocess and control proceduresSupported testing of raw materials Show less

Executed successful qualification of alternate supplier for single-sourced componentDevelopment testing of medical injection systems to support product designPreparation of samples, functional testing, evaluation of product quality, and analysis and reporting of results.Test criteria and methods adhere to government and company protocolWorking knowledge of Good Laboratory Practices, State of NJ and federal laboratory safety practices, ISO requirements