Quality Assurance Specialist II - Viral Vector

QualityAssuranceSpecialistII-ViralVectorLocation:Houston,Texas–OnsiteShift:SundaythroughThursday,7:00AM–3:30PMAsaQualityAssuranceSpecialistII-ViralVector, you will serve as a key representative of the Quality Assurance organization, ensuring quality and compliance standards are maintained across viral vector and advanced therapy manufacturingoperations.ThisroleprovidestheopportunitytopartnercloselywithManufacturing,QualityControl,Engineering,andothersupportfunctionstosupportproductionactivities,maintaincGMPcompliance,andhelpdeliverlife-changingtherapiestopatients. Whatyouwillget:Acompetitivecompensationpackage.Inaddition,belowyouwillfindacomprehensivesummaryofthebenefitspackageweoffer:Performance-relatedbonusMedical,dentalandvisioninsurance401(k)matchingplanLifeinsurance,aswellasshort-termandlong-termdisabilityinsuranceEmployeeassistanceprogramsPaidtimeoff(PTO)Compensationforthisrolewillbedeterminedbythecandidate’squalifications,skills,experience,andrelevantknowledge.Whatyouwilldo:Providequalityoversightforviralvectorandcelltherapymanufacturingoperations,ensuringcompliancewithcGMP,GDP,andqualitysystemrequirements. SupportmanufacturingflooractivitiesthroughQApresenceonthefloor,includinglineclearances,criticaloperationssupport,andquality-relateddecisionmaking. ReviewandapproveMasterBatchRecords,executedbatchrecords,andsupportingGMPdocumentationtosupportproductdispositionandmanufacturingexecution. PerformQAwalkthroughsandcollaboratewithManufacturingandsupportgroupstoidentify,investigate,andresolvequalityandcomplianceissues. Supportinvestigations,deviations,CAPAs,changecontrols,andotherqualitysystemprocessesusingstructuredproblem-solvingapproaches.EnsurecompliancewithISO,GMP,andregulatoryrequirementswhilemaintaininginspectionreadiness. PerformcleanroomactivitiesrequiringLevel3gowning(GradeB)tosupportmanufacturingoperationsandqualityoversight. Maintainaccuratetrackingofqualityrecordsandsupportcontinuousimprovementinitiativesthatstrengthenqualityandoperationalexcellence. Whatwearelookingfor:AssociatesdegreeinLifeSciences,Engineering,orarelatedscientificdisciplinepreferred.Relevantindustryexperiencemaybeconsideredinlieuofdegreerequirements.ExperienceworkinginaGMP-regulatedbiopharmaceutical,biologics,celltherapy,orviralvectormanufacturingenvironment. Hands-oncleanroomandgowningexperience,includingtheabilitytoworkwithinclassifiedmanufacturingenvironments. ExperiencereviewingGMPdocumentationandbatchrecordswithstrongattentiontodetail. Knowledgeofdeviations,CAPAs,changecontrols,andqualitysystemsprocessespreferred. Strongcommunicationskillsandtheabilitytoeffectivelycollaboratewithcross-functionalteams. Demonstratedproblem-solvingskillsandtheabilitytomakesounddecisionsinafast-pacedmanufacturingenvironment. Celltherapyand/orviralvectormanufacturingexperiencepreferred. Strongworkethic,proactivemindset,andcommitmenttoquality,compliance,andpatientsafety. AboutLonzaAt Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence,PassionandIntegrityreflectwhoweareandhowweworktogether.Everyone’sideas,bigorsmall,havethepotentialtoimprovemillionsoflives,andthat’sthekindofworkwewantyoutobepartof.Innovationthriveswhenpeoplefromallbackgroundsbringtheiruniqueperspectivestothetable.AtLonza,weofferequalemploymentopportunitiestoallqualifiedapplicantsregardlessofrace,religion,color,nationalorigin,sex,sexualorientation,genderidentity,age,disability,veteranstatus,oranyothercharacteristicprotectedbylaw.Ifyou'rereadytohelpturnbreakthroughscienceintolife-changingtherapies,welookforwardtowelcomingyouonboard.Readytoshapethefutureoflifesciences?Applynow.SummaryLocation: US - Houston, TXType: Full time