Lonza
Quality Assurance Specialist II - Viral Vector
United States · Work style not stated · Full time
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About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerLonza
- LocationUnited States
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
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 therapy manufacturingoperations.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)
Show full description
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.
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- USD a year, after annualising30–200,000 (11 listings, 5 employers)
At a glance
- Employment typeFull time
- Employer posted
- Added to ROLIVA
- Last checked