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.

Quality Control Specialist

Position Overview The  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.

Position Summary The  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.

The Quality Control Specialistcontributestodepartmentalobjectivesbyworkingindependently ,managingmultiplepriorities,completingassignedprojectswithinestablishedtimelines,andmaintainingeffectivecommunicationwithinternalstakeholders.

Core Values&Behaviors Recognize,exemplify,andadheretoICON'svaluescenteredon

People,Clients,and Performance.

Embraceandcontributetoacultureofcontinuousimprovementfocusedonenhancingefficiency,quality,compliance,andcustomersatisfaction.

Demonstrateastrongcommitmenttoquality,accuracy,integrity,andregulatorycompliance.

Collaborateeffectivelywithinateamenvironmentandcontributetodepartmentalandorganizationalgoals.

Communicateprofessionallyandeffectivelywithsupervisors,colleagues,Project Leaders,Project Managers,andcross-functional teams.

Prioritizeworkloadeffectivelyandmanagetimetomeetdeadlines.

Maintainpunctualandreliableattendanceinaccordancewithcompanypolicy.

Adheretoallsafetyproceduresandmaintainasafeworkingenvironment.

Key Responsibilities Data Review &Compliance Performqualitycontrol(QC) reviewofstudyparticipantresultsandlaboratoryrunpacketstoensureaccuracy,completeness,andcompliancewithapplicableSOPs,protocols,andregulatoryrequirements.

Conductreviewof Biomarker Reportsandsupportingstudydocumentationtoverifydataaccuracyandintegrity .PerformQCreviewofvalidationdocumentationandassociatedrecords.

Review methods,reports,studydata,andsupportingdocumentationforaccuracy,consistency,completeness,andproperformatting.

Identify,document,andcommunicatedatadiscrepancies,quality issues,andcomplianceconcernsinatimelymanner.

Assistwithinvestigationsandresolutionofdataanddocumentationdiscrepanciestosupportstudyintegrityandqualityobjectives.

Providebackupsupportfor Incoming Materialsreviewactivitiesand QCreviewof Production Batch Records .Read,understand,andcomplywithSOPs,safety requirements,regulatory guidelines,andcompany policies.

Documentation&Records Management Maintain accurate ,complete,andaudit-readyrecordsinaccordancewithregulatory,client,andcompany requirements.

Supportdocumentcontrolactivities,includingthecreation,review,revision,maintenance,andarchivalofcontrolleddocumentation.

Developandsupportimprovementstodocumentcontrolprocessestoenhancecompliance,organization,efficiency,and traceability.

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