檢測技術專員崗位職責

職責描述:

1.負責審核分公司檢測管理文件,統一管理體系

2.協助檢測系統審計準備,審核CAPA,跟蹤缺陷整改

3.實驗室異常管理、統計分析,負責組織檢測系統技術提升計劃的制定與實施

4.通過對方法驗證、確認、轉移報告的審核,統一各檢測機構方案,確保公司的分析方法驗證、確認、轉移對法規的符合性與先進性

5.負責公司委托檢測管理工作,確保委托檢測實驗室的合規性

任職要求:

1.教育背景:本科及以上學歷,藥學相關專業;

2.工作經驗:本科3年以上QC工作經驗;研究生1年以上QC工作經驗;

3.專業技能:熟悉QC日常檢測技能,有分析方法驗證經驗,熟悉QC現場GMP管理

4.綜合素質:有較強協調及溝通能力;分析、判斷、學習、創新能力強;良好的職業道德和職業操守

檢測技術專員崗位

篇2:實驗室檢測技術員崗位職責實驗室檢測技術員職責任職要求

實驗室檢測技術員崗位職責

崗位職責:

1.從事熒光定量PCR、一代/二代測序等實驗基本操作及數據分析等工作;

2.及時處理臨床和市場部反饋的信息;

3.撰寫SOP等文件和報告;

4.按照實驗室的質量控制要求,填寫相關記錄表單,維護實驗儀器,保持實驗技術平臺的正常運轉。

任職資格:

1、分子生物學、醫學檢驗相關專業本科及以上學歷;

2、具有分子檢測技術平臺(PCR、測序、FISH等)經驗者優先考慮;

3、有檢驗師資格證者或PCR上崗證者優先考慮;

4、誠實正直,工作認真嚴謹,具有良好的團隊合作精神,具有高度的責任感和敬業精神。

篇3:基因檢測技術員崗位職責基因檢測技術員職責任職要求

基因檢測技術員崗位職責

MedicalTechnologist-Genomics基因檢測技術員科文斯醫藥研發科文斯醫藥研發(北京)有限公司上海分公司,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.