Quality Control Specialist

Quality Control Specialist - Portland, Oregon (OR)ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.QualityControlSpecialistPositionOverviewThe Quality Control Specialist plays a critical role in ensuring the accuracy, integrity, and compliance of laboratory data, documentation, and quality records. This position performs quality control reviews of study-related data and laboratory documentation, supports quality systems and document control processes, monitors laboratory quality metrics, andcontributestocontinuousimprovementinitiatives.Theidealcandidateishighlydetail-oriented,analytical,andcommittedtomaintainingthehigheststandardsofqualityandregulatorycompliancewithinaregulatedlaboratoryenvironment.PositionSummaryThe Quality Control Specialist is responsible for the review, verification, and maintenance of laboratory data, documentation, and quality records in accordance with established Standard Operating Procedures (SOPs), study protocols, analytical methods, and regulatory requirements.Thisrolecollaboratescross-functionallytoensuredataintegrity,compliance,andconsistencyacrosslaboratoryoperationswhilesupportingqualitysystems,laboratorymetricsreporting,documentcontrolinitiatives,andcontinuousimprovementefforts.TheQualityControlSpecialistcontributestodepartmentalobjectivesbyworkingindependently,managingmultiplepriorities,completingassignedprojectswithinestablishedtimelines,andmaintainingeffectivecommunicationwithinternalstakeholders.CoreValues&BehaviorsRecognize,exemplify,andadheretoICON'svaluescenteredonPeople,Clients,andPerformance.Embraceandcontributetoacultureofcontinuousimprovementfocusedonenhancingefficiency,quality,compliance,andcustomersatisfaction.Demonstrateastrongcommitmenttoquality,accuracy,integrity,andregulatorycompliance.Collaborateeffectivelywithinateamenvironmentandcontributetodepartmentalandorganizationalgoals.Communicateprofessionallyandeffectivelywithsupervisors,colleagues,ProjectLeaders,ProjectManagers,andcross-functionalteams.Prioritizeworkloadeffectivelyandmanagetimetomeetdeadlines.Maintainpunctualandreliableattendanceinaccordancewithcompanypolicy.Adheretoallsafetyproceduresandmaintainasafeworkingenvironment.KeyResponsibilitiesDataReview&CompliancePerformqualitycontrol(QC)reviewofstudyparticipantresultsandlaboratoryrunpacketstoensureaccuracy,completeness,andcompliancewithapplicableSOPs,protocols,andregulatoryrequirements.ConductreviewofBiomarkerReportsandsupportingstudydocumentationtoverifydataaccuracyandintegrity.PerformQCreviewofvalidationdocumentationandassociatedrecords.Reviewmethods,reports,studydata,andsupportingdocumentationforaccuracy,consistency,completeness,andproperformatting.Identify,document,andcommunicatedatadiscrepancies,qualityissues,andcomplianceconcernsinatimelymanner.Assistwithinvestigationsandresolutionofdataanddocumentationdiscrepanciestosupportstudyintegrityandqualityobjectives.ProvidebackupsupportforIncomingMaterialsreviewactivitiesandQCreviewofProductionBatchRecords.Read,understand,andcomplywithSOPs,safetyrequirements,regulatoryguidelines,andcompanypolicies.Documentation&RecordsManagementMaintainaccurate,complete,andaudit-readyrecordsinaccordancewithregulatory,client,andcompanyrequirements.Supportdocumentcontrolactivities,includingthecreation,review,revision,maintenance,andarchivalofcontrolleddocumentation.Developandsupportimprovementstodocumentcontrolprocessestoenhancecompliance,organization,efficiency,andtraceability.Compilelaboratorynotebooks,departmentalrecords,andsupportingdocumentationforarchivalandregulatorycompliance.Ensuredocumentationpracticesremainconsistent,accurate,organized,andinspection-ready.QualitySystems&ContinuousImprovementCompile,maintain,analyze,andreportlaboratoryqualitymetricsandkeyperformanceindicators.Developandmaintaintrackingtoolsrelatedtoqualityevents,deviations,errors,andlaboratorytrends.Identifyopportunitiesforprocessimprovementthroughtrendanalysis,qualityassessments,andoperationalobservations.Supportcontinuousimprovementinitiativesfocusedonqualitysystems,documentationpractices,compliance,andoperationalefficiency.RespondtoQualityAssuranceobservationsandassistwithcorrectiveandpreventiveactions(CAPAs)asrequired.Participateinsponsoraudits,regulatoryinspections,andqualityassessmentsasneeded.Cross-FunctionalSupportCollaboratewithlaboratory,operations,projectmanagement,andqualityteamstoensuretimelycompletionofqualityreviewactivities.Supportdepartmentalprojectsandinitiativesaimedatimprovingcompliance,consistency,andoveralllaboratoryperformance.Performadditionaldutiesasassignedbymanagement.Participateintrainingandprofessionaldevelopmentactivitiestomaintainknowledgeofindustryregulationsandbestpractices.Qualifications&ExperienceRequiredQualificationsMinimumoffive(5)yearsoflaboratoryexperienceinaregulatedenvironment.WorkingknowledgeofGxPregulationsandapplicableindustryguidancedocuments.ProficiencywithMicrosoftOfficeSuiteapplications.Experienceutilizinglaboratoryinstrumentdatasystems.Strongattentiontodetailandcommitmenttodataintegrity.Excellentorganizational,communication,andproblem-solvingskills.Abilitytoworkindependentlywhilecollaboratingeffectivelyacrossmultipledepartments.PreferredQualificationsExperienceusingJMPstatisticalsoftwarefordataanalysis,trending,reporting,andvisualizationoflaboratoryqualitymetrics.Experiencesupportingsponsoraudits,regulatoryinspections,andqualityassessments.Knowledgeoflaboratoryqualitysystems,documentcontrolprocesses,dataintegrityrequirements,andGoodDocumentationPractices(GDP).Experienceanalyzingqualitymetrics,deviations,investigations,CAPAs,andlaboratoryperformancetrends.Experienceperformingqualitycontrolreviewsofscientificdata,validationdocumentation,reports,andregulatedlaboratoryrecords.Experienceworkingwithinapharmaceutical,biotechnology,contractresearchorganization(CRO),orotherregulatedlaboratoryenvironment.Demonstratedabilitytoidentifyprocessimprovementopportunitiesandcontributetocontinuousimprovementinitiatives.Experiencecollaboratingcross-functionallywithlaboratoryoperations,QualityAssurance,ProjectManagement,andothertechnicalstakeholders.WorkingConditionsPrimarilylaboratoryandoffice-basedworkenvironment.Extendedperiodsofcomputer-basedworkanddocumentreview.Abilitytomanagemultipleprioritiesanddeadlinesinaregulatedenvironment.Mayparticipateinaudits,inspections,andcross-functionalprojectactivitiesasrequired.#LI-HD1Employment with ICON is contingent upon having the legal right to work in the country where the role is based.Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.Benefits may include:Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.Visit our careers site to read more about the benefits ICON offers.Inclusion and AccessibilityICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.Are you a current ICON Employee? Please click here to applySummaryLocation: US, Portland, ORType: Full time