基因检测技术员岗位职责

MedicalTechnologist-Genomics基因检测技术员科文斯医药研发科文斯医药研发(北京)有限公司上海分公司,科文斯医药研发,科文斯Responsibilities/Duties:

♦Performassignedclinicallaboratorytestingaccuratelyandinatimelymanner.

oResolvependings.Retrieveandcheckspecimensagainstpendinglist.Documentspecimendiscrepancies.Notifylaboratorymanagementwhenspecimendiscrepanciesarenotresolved.

oPrepareworkstationandinstrumentationfortheassignedtesting.oProperlyhandlespecimensandindependentlyresolvetechnicalspecimenissuesinpreparationforanalysisandspecimenstorage.Contactinternalcustomersforclarificationasneeded.

oOperateinstrumentstoperformtestinginaccordancewithestablishedwrittenprocedures.

oPerformsroutinetestingandcalculationsasrequired.

oResolveroutineandnon-routineassayproblems.

♦Ensurethevalidityoftestsresultsthroughtheperformanceofestablishedqualityassuranceandqualitycontrolprocedures.

oPerformexperiments,asscheduled,forevaluationofnewCalibratorand/orQClots.Summarizeresultsofinvestigationsandcompiledataforreviewbymanagement.

oDocumentqualitycontrolresults.InterpretqualitycontrolresultsaccordingtoWestgardrulesorotherestablisheddepartmentalproceduresandaccuratelydocumentbiases,warningsandviolationsofcontrolvalues.

oDocumentcorrectiveactionforunusualoccurrences(e.g.QCviolations,instrumentrelatedproblems).

oAnalyzeproficiencytestingsurveysamplesaspatientspecimens.♦Reagents/Materials/Supplies:

oReceive,openandplaceinserviceallreagents/materialsaccordingtoSOPs.

oPrepareandproperlylabelreagent,qualitycontrol,calibratormaterial.

oDocumentimplementationofnewreagents/materialsaccordingtoSOPs.

oPerformparalleltesting,linearity’s,stability,otherqualitycontrolpracticesneededtoensurevalidityofmaterialpriortobeingplacedintoservice.

oPerforminventorycontrolofsuppliesandreagentsasapprovedbymanagement.

♦ResultEntry(Auto-verificationandmanualentry).

oWhendataismanuallyentered(e.g.QC,patientdata)ensurepeerreviewisperformedanddocumentedpriortoreleaseofresults.

oPrepareproperdocumentationoftestresultsandenterintotheinformationsystem.

oGenerateanappropriateaudittrailforallactivities.

oDocumentandcommunicateanyresultreportingproblemsorinconsistenciestolaboratorymanagement.

oCompletetestingwithintheexpectedturnaroundtimetomeetcustomers’expectations.

♦EnsuresmaintenanceofinstrumentsandequipmentisperformedaccordingtomanufacturerandSOPrequirements,anddocumentedaccordingtoSOP.oCalibrateinstruments,equipmentand/orassaysasrequiredanddocument.

oPerformbasicinstrumentandequipmenttroubleshooting.

oPerformpipettecalibrationsanddocumentaccordingtoSOP.

oNotifylaboratorymanagementwhenaninstrumentorequipmentdoesnotmeetspecifications.

♦ComplywithregulatoryguidelinesandCovanceStandardOperatingProcedures(SOPs)atalltimes.

♦Training

oIndividualisresponsibleformaintaininghis/hercompleteup-to-datetrainingfileandisaccountableforcorrectinganddeficienciesfoundinhis/hertrainingfile.

oIndividualisresponsibleforensuringhe/sheistrainedandtrainingisdocumentedpriortoperformingatask.

oTheindividualsuccessfullycompletes,asscheduled,competencyassessmentandensurescompetencytestingdocumentationisprovidedtomanagementforreview/retention.

oCompetentlyperformsdepartmentdutiesassetforthinthedepartmenttrainingchecklist(s).

oMayassistintrainingnewemployeesandfollows-uptoensuretrainingisunderstood.

oAttends,asscheduled,department,mandatoryandothermeetingsandtraining,asrequiredaccordingtotrainingmatrices.

♦Worktoachievepartnershipwithbothinternalcustomersandexternalclientsby:

oPulldatainatimelymannerforreviewbyQAandexternalclients.

oContributetotheprovisionofaccurateverbalorwrittenresponsetointernalQAandclientauditfindings.Coordinate,whereneeded,withotherresourcestoresolveissue.

oResearchesandpreparesaresponsefollowinginvestigationforqualitypurposes.Coordinate,whereneeded,withotherresourcestoresolveissue.

oResearchandrespondsinatimelymannertointernalcustomerinquiriesregardingstatusoftestresults,retrievalofsamplesfortesting/storageandotherneeds.

oUnderstanddepartmentmetricsandgoals.

♦Demonstrateproficiencyinapplicablecomputersystemsandsoftware.

♦AdherestoestablishedSafetypoliciesandUniversalprecautionguidelinesatalltimes.Maintainsaclean,organizedandsafeworkenvironment.Minimizesbiohazardwaste.Cleansworkstationandmaterialsdaily.

♦Takesactionforthedepartmentwhenadditionalresponsibilitiesandopportunitiesarepresented.

♦Providelaboratorymanagementwithareportofactivitiesuponrequest.

♦Otherdutiesasassigned.

Education/Qualifications

Required:

•IndividualmustqualifyastestingpersonnelunderMoHregulations.

Preferred:

•Bachelor'sdegreeinMedicalTechnologyorcompletionofatleasta12-monthtrainingprograminMedicalTechnology.

OR

•Bachelor'sdegreeinachemical,physicalorbiologicalsciencefromanaccreditedcollegeoruniversityandoneyeartrainingand/orexperienceinthespecialtyinwhichtestingistobeperformed.SuchtrainingmustbeequivalenttothatreceivedinaschoolofMedicalTechnology.

Experience

1yearlabexperience,chemistrydepartmentprefer.