檢測(cè)技術(shù)專員崗位職責(zé)

職責(zé)描述:

1.負(fù)責(zé)審核分公司檢測(cè)管理文件,統(tǒng)一管理體系

2.協(xié)助檢測(cè)系統(tǒng)審計(jì)準(zhǔn)備,審核CAPA,跟蹤缺陷整改

3.實(shí)驗(yàn)室異常管理、統(tǒng)計(jì)分析,負(fù)責(zé)組織檢測(cè)系統(tǒng)技術(shù)提升計(jì)劃的制定與實(shí)施

4.通過(guò)對(duì)方法驗(yàn)證、確認(rèn)、轉(zhuǎn)移報(bào)告的審核,統(tǒng)一各檢測(cè)機(jī)構(gòu)方案,確保公司的分析方法驗(yàn)證、確認(rèn)、轉(zhuǎn)移對(duì)法規(guī)的符合性與先進(jìn)性

5.負(fù)責(zé)公司委托檢測(cè)管理工作,確保委托檢測(cè)實(shí)驗(yàn)室的合規(guī)性

任職要求:

1.教育背景:本科及以上學(xué)歷,藥學(xué)相關(guān)專業(yè);

2.工作經(jīng)驗(yàn):本科3年以上QC工作經(jīng)驗(yàn);研究生1年以上QC工作經(jīng)驗(yàn);

3.專業(yè)技能:熟悉QC日常檢測(cè)技能,有分析方法驗(yàn)證經(jīng)驗(yàn),熟悉QC現(xiàn)場(chǎng)GMP管理

4.綜合素質(zhì):有較強(qiáng)協(xié)調(diào)及溝通能力;分析、判斷、學(xué)習(xí)、創(chuàng)新能力強(qiáng);良好的職業(yè)道德和職業(yè)操守

檢測(cè)技術(shù)專員崗位

篇2:實(shí)驗(yàn)室檢測(cè)技術(shù)員崗位職責(zé)實(shí)驗(yàn)室檢測(cè)技術(shù)員職責(zé)任職要求

實(shí)驗(yàn)室檢測(cè)技術(shù)員崗位職責(zé)

崗位職責(zé):

1.從事熒光定量PCR、一代/二代測(cè)序等實(shí)驗(yàn)基本操作及數(shù)據(jù)分析等工作;

2.及時(shí)處理臨床和市場(chǎng)部反饋的信息;

3.撰寫SOP等文件和報(bào)告;

4.按照實(shí)驗(yàn)室的質(zhì)量控制要求,填寫相關(guān)記錄表單,維護(hù)實(shí)驗(yàn)儀器,保持實(shí)驗(yàn)技術(shù)平臺(tái)的正常運(yùn)轉(zhuǎn)。

任職資格:

1、分子生物學(xué)、醫(yī)學(xué)檢驗(yàn)相關(guān)專業(yè)本科及以上學(xué)歷;

2、具有分子檢測(cè)技術(shù)平臺(tái)(PCR、測(cè)序、FISH等)經(jīng)驗(yàn)者優(yōu)先考慮;

3、有檢驗(yàn)師資格證者或PCR上崗證者優(yōu)先考慮;

4、誠(chéng)實(shí)正直,工作認(rèn)真嚴(yán)謹(jǐn),具有良好的團(tuán)隊(duì)合作精神,具有高度的責(zé)任感和敬業(yè)精神。

篇3:基因檢測(cè)技術(shù)員崗位職責(zé)基因檢測(cè)技術(shù)員職責(zé)任職要求

基因檢測(cè)技術(shù)員崗位職責(zé)

MedicalTechnologist-Genomics基因檢測(cè)技術(shù)員科文斯醫(yī)藥研發(fā)科文斯醫(yī)藥研發(fā)(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.