Quality Assurance Specialist II - Viral Vector

QualityAssuranceSpecialistII-ViralVector

Location:Houston,Texas–Onsite

Shift: Sunday through Thursday,7:00AM– 3:30PM

AsaQualityAssuranceSpecialistII-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 therapymanufacturingoperations.ThisroleprovidestheopportunitytopartnercloselywithManufacturing,QualityControl,Engineering,andothersupportfunctionstosupportproductionactivities,maintaincGMPcompliance,andhelpdeliverlife-changingtherapiestopatients.

Whatyouwillget:

Acompetitivecompensationpackage.Inaddition,belowyouwillfindacomprehensivesummaryofthebenefitspackageweoffer:

• Performance-relatedbonus
• Medical,dentalandvisioninsurance
• 401(k)matchingplan
• Lifeinsurance,aswellasshort-termandlong-termdisabilityinsurance
• Employeeassistanceprograms
• Paidtimeoff(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.

AboutLonza

At 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.