BiOMARIN.

JobTitle:QualityControlAnalystEmployeeType:PermanentLocation:Ireland-Cork

BioMarininIreland

InIreland,BioMarinoperatesaBiopharmaManufacturingSiteinShanbally,Co.Cork,andaGlobalCommercialOperationsHubinDublin.

Whatmakesworkinghereunique?AtBioMarin,wefeeltheintensetiebetweentheworkwedoandthelife-changingresultsitdelivers.Ourfocusonrarediseasegivesustherareopportunitytotrulyimpactlives.AsBioMarinemployees,we'reherebecausewewanttobehere.Weenjoyourwork-andeachother.Ourpeoplearesmart.Unassuming.Collaborative.Curious.Interesting.Inreturn,thereisdevelopment,empowermentandtotalreward.

RoleSummary

Weareahigh-performing,teambasedorganisation,wherecolleaguesareflexible,multi­skilledandempoweredtomakedecisions.Ahighlevelofinitiative, energy andmotivationarekeyrolerequirements,aswellasorganisationalskills.

ReportingtotheQCTeamLeader,theprimaryroleoftheQCAnalystistoprovidesupporttointernalandexternalcustomersbyprovidingqualitytestinganddeliveringresultsinaccordancewithGMPstandards.Ensuringourproductsaresafeforpatientuseandfitforpurpose.

Theteam isdividedinto3sub-teamsQCAnalytical;QCMicrobiologyandQCIn-Process. Therolecouldpotentiallyliewithinanyofthesesub-teamsdependingonexperienceandrequirement.

RoleResponsibilities

Therolepotentiallywillcover Microbiology testingincludingbutnotlimitedtothefollowing:

•Microbiologicaltestingperformedbythelabincl:EM;Utilities;Bioburden;Endotoxin;GrowthPromotion&Bis

•Supporting activities in Drug Product – including media fills

•Supporting method development and validation

•PerformprimaryreviewofQCrawdataandtrendresults

·•Prepare protocols,summaries,and reports-oftenfor direct submission topharmaceuticalregulatoryagencies

•Develop,optimize,validateandtroubleshoottestmethods

•DraftQCSOPs

•Actastechnical resource(SME)andtrainotheranalystsinareasofexpertise

•Evaluateresultsagainstdefinedacceptancecriteria

•Conductanddocumentlaboratoryinvestigationstocompletion

•Maintainthelaboratoryinaninspection-readystate

•Interactdirectlywithregulatoryagencyinspectorsduring audits

•Interface withother  BioMarin departments (Manufacturing, Quality Assurance,Facilities,etc.)andcontractorsasnecessary

•Excellentcommunicationskillsbothwrittenandverbal

•Customerfocus; takespersonal responsibilityforspeed;qualityandaccuracy of delivery

•Self-motivatedandabilitytoworkunderpressure

•Team Leadership-active participationteam  development  andcontinuousimprovementincludingstandardworkand5S

•Successful trackrecordinachievinggoalsaspartofateamwithinagrowing,dynamicenvironment

•DemonstratedadaptabilityandflexibilitytosupportagrowingorganisationEducationRequired

•B.S.inascientificdisciplinewith3+ yearsofrelevantlaboratoryexperience.ExperienceRequired

•Abilitytoworkindependentlyandmeetingestablishedtimelines.

•Comfortwithcoordinatingtheactivitieswithotherstaffmembers.

•Comfortwithworkinginateamenvironment

•KnowledgeofcGMPs.SupervisorResponsibility

•NodirectreportsCompetencies Required

Behavioral

AccountabilityAchievingExcellenceCommunicationCourageIChallengeDevelopSelf&OthersJudgement

ReliabilityTeamwork

Technical

TechnicalKnowledge&ExpertiseAttentiontoDetail

ComplianceDocumentationITApplications

Workload&TimeManagement

Note:Thisdescriptionisnotintendedtobeall-inclusive,oralimitationofthedutiesofthe position.Itisintendedtodescribethegeneralnatureofthejobthatmayincludeotherdutiesasassumedorassigned.

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