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QC Analyst - Day Position (TEMPORARY)

Location Cork, Ireland

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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Cork

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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