Quality Assurance Manager

1 month ago


Milton, Ontario, Canada CB Canada Full time

pAreyoulookingtomakeadifferenceinapatient'slife?AtAmerisourceBergen,youwillfindaninnovativeandcollaborativeculturethatispatient-focusedanddedicatedtomakingadifference.Asanorganization,weareunitedinourresponsibilitytocreatehealthierfutures.WeareseekingahighlyskilledQualityAssuranceManagertojoinourteaminMilton,Ontario.ThesuccessfulcandidatewillberesponsibleforensuringthatallQualityAssurancereleaseactivitiesassociatedwith3PLoperationsarecompletedincompliancewiththeGMPsandinaccordancewithcontractualobligations./pbrbrbKeyResponsibilities:/bbrbrulliManageateamofQAReleaseSpecialistsandAssociates,assigningday-to-dayactivitiesandprovidingregulardirection,mentoring,andcoachingtotheteam./liliDevelopeffectiverelationshipswithOperationsManagementinordertoensurethattheMiltonWarehouseandInnomarDCsaremaintainedinastateofGMPcompliance./liliActivelycontributetothedevelopment,maintenance,andimprovementoftheInnomarGMPQualitySystems./liliActasprimaryhostforclientaudits,includingpreparingtheformalresponses,andprovidesupportduringregulatoryinspectionsandcorporateaudits./liliExecutetheinternalauditprogramandensurethatanyadversetrendsarecommunicatedtoseniorQAmanagement./liliProvidesupporttotheSeniorManager,QAGMPwithmanagementofboththedeviationprogramandthechangecontrolprogram./liliPreparequarterlytrendreportsforkeyqualityindicatorsandpresentthesetrendstoManagement./liliProvidesupporttotheSeniorManager,QAGMPforProductRecalls,includingcustomernotification,coordinationofcustomerreturns,andmaintainingdocumentation./liliEnsurethatMockRecallsarerunannuallytomeetGMPrequirementsforDrugs,NHPs,andmedicaldevices,withinallinventorymanagementsystemsutilizedatInnomar./liliAdministerthevendormanagementprogram,includingthereview,evaluation,andapprovalofserviceproviders./liliSupportthefacilityandequipmentqualificationprograms,whichincludestemperaturemappingofthewarehouse,refrigerators,andfreezers,executionoflanestudies,andvalidationofpack-outs./liliProvideleadershipanddirectiontotheQAteamintheabsenceofbothSeniorManager,QAGMP./liliWorkwiththerestoftheQAmanagementteaminthedevelopment/revisionandimplementationofQApoliciesandproceduresasrequired./liliUnderstandandapplycompanyConfidentialityandPrivacyAgreements./liliTravelsupto20%ofthetime./liliOtherdutiesandtasksthatmay,fromtimetotime,beassignedbySeniorQAManagement./liliMayberequiredtobeonstandby/oncallaspartofthisrole./li/ulbrbrbRequirements:/bbrbrulliBachelor'sofSciencedegreeinapharmaceuticalorhealthcare-relatedfield(e.g.,chemistry,microbiology,pharmacy,andpharmacology)./liliMinimumof6years'experienceinQualityAssurance./liliExperienceinconductingvendoraudits./liliExperienceinhosting/co-hostingclientauditsisconsideredanasset./liliExperienceworkinginanOperations/Warehouseenvironmentisconsideredanasset./li/ulbrbrbWhatWeOffer:/bbrbrpWeoffercompetitivetotalrewardscompensation.Ourcommitmenttoourassociatesincludesbenefitprogramsthatarecomprehensive,diverse,anddesignedtomeetthevariousneedsacrossourassociatepopulation./pbrbrbEqualEmploymentOpportunity:/bbrbrpAmerisourceBergeniscommittedtoprovidingequalemploymentopportunitywithoutregardtorace,color,religion,sex,sexualorientation,genderidentity,geneticinformation,nationalorigin,age,disability,veteranstatus,ormembershipinanyotherclassprotectedbyfederal,state,orlocallaw./p



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