process improvement specialist 2011-11

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  • 8/3/2019 Process Improvement Specialist 2011-11

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    Position: ProcessImprovementSpecialistIReportsto: DirectorofBiotechnologyDepartment: ProcessImprovementDateRevised: November2011FLSAStatus: Exempt(salary)Scope:TheProcessImprovement(PI)Specialistprovidesthecompanywithexpertiseinthevariousprocessesinvolved

    inthemanufacturingofpoultryvaccines.Theindividualwillberesponsibleforperformingexperimental

    proceduresnecessarytoidentify,analyze,andimproveexistingmanufacturingprocessesandproductquality.

    Inadditiontotheexperimentalduties,theincumbentwillberesponsibleforthecreationandrevisionof

    instructionaldocuments,StandardOperatingProcedures(SOPs),productiontracking,dataanalysis,andtrial

    reports. ThePISpecialistwillbeacoreteammemberonprocessdevelopmentprojects. Theincumbentwill

    workclosely

    with

    the

    Production

    Department,

    Quality

    Control

    Department

    (QC),

    and

    Research

    &

    Development

    Department(R&D)todesign,develop,andtracknewmanufacturingprocesses,andproducts,inaccordance

    withUSDAand9CFRregulations.

    DutiesandResponsibilities:1. Designs,coordinates,andexecutestrialsandprojects,bothindependentlyandincollaborationwithcrossfunctionaldepartments. Indoingso,incumbentmustensurenecessaryresourcesarescheduled

    andmadeavailable,activitieswithinandbetweendepartmentsarecoordinated,trialprotocolsand

    objectivesaredevelopedandadheredto,andtherequireddataforanalysisisretrievedand

    documented. AsoundworkingrelationshipwiththeR&D,QC,AvianServices,Productionand

    RegulatoryDepartmentsisessentialtosuccessfullyaccomplishtrialandprojectobjectives.

    2. Createsmonitoringmethods,suchaschartsandgraphs,toassisttheteamandotherdepartmentsinrecognizingthesuccessofnewlyimplementedproceduresortechnologies,andinrecognizing

    downwardtrendsinperformancebeforedetrimentaleffectstotheproductoccur.

    3. Collaborateswiththeappropriatedepartmenthead,supervisorand/ormanagertounderstandscheduledemandsandarrangedailytaskstoachievedepartmentalandcompanywideobjectives.

    4. CollaborateswithotherProcessImprovementSpecialists,underthedirectionoftheDirectorofBiotechnology,toprovidescientificguidanceandassistancetoresolvetechnicalproblemsinthe

    ProductionDepartment.

    5. Progressivelyundertakesareviewandanalysisofproductionactivitiesandmethodologiestoensurecompliance

    with

    the

    approved

    Outlines

    of

    Production.

    6. UndertheguidanceoftheDirectorofBiotechnology,providesrecommendationsandimplementsprocesschangesincollaborationwiththeotherProcessImprovementSpecialistsandcrossfunctional

    projectteamstoensurecompliancewithcompanyobjectivesandtherequirementsof9CFR.

    7. CreatesorrevisesSOPstocoverallprocedureswithinthePIDepartmentandaspectsofprocesschangeswithinthecompany.Theuseofphoto/pictureSOPsisencouraged.

    8. Documentstrialsandsubmitsreportscontaininganyrecommendedchangesincurrentpracticesandprocedures.

    Job Description

  • 8/3/2019 Process Improvement Specialist 2011-11

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    9. Collaborateswithproject teammembers,clients,vendors,anduppermanagement to facilitateandachieveprojectgoals.

    10.Collaboratesinallaspectsoftechnologytransferandlaunchingnewprocessesintoproduction.11.Presentsscientificdataandstatusreportsforpeerreviewto individuals insmallgroups,departmentheads,andtechnicalteams,aswellassummaryreportsatcompanywidemeetings.

    12.Will assist the Director of Biotechnology in the implementation of new testing using molecularbiotechnologytechniques,includingPCRandRTPCR.

    13.Weekendandoffhourworkmaybeoccasionallynecessary.14.OtherdutiesasassignedbytheDirectorofBiotechnology.

    Qualifications:MusthaveaminimumofaBachelorsDegreeinbiology,microbiology,oranengineeringdiscipline. Recent

    recipientsofaMastersDegreewithexperienceinmolecularbiotechnologypreferred. Significantdirect

    experiencein

    vaccine

    production

    is

    highly

    desirable.

    Aworkingknowledgeofmathematicsandbasicformulationsisessential,asistheabilitytogather,organize,

    analyze,document,andpresentdata.Theincumbentmustbeabletoindependentlycomposereportsand

    presentationstoeffectivelycommunicatewithmanagementandotherdepartments.Musthavesound

    judgment,aswellasexcellentplanning,organizing,interpersonal,oralandwrittencommunicationskills. The

    abilitytoachievegoals,coupledwithtenacityandreasonedanalysesisrequired. Theincumbentmustbea

    selfmotivatedteamplayerwithapositiveattitudeandacommitmenttomeetingtargets. Flexibilityand

    adaptabilityarekeytraitscoupledwiththeinitiativetoresolveproblems.MustbeproficientwithMSWord

    andExcel.

    Note:AllLohmannAnimalHealthInternationaljobdescriptionsareguidelinestoassistemployeesinawarenessofqualificationsandperformanceexpectationsfortheirrespectivepositions. Itisnotpossibleordesirabletocommiteverydetailedaspectofeachjobtoawrittendescription. Eachemployeeisexpectedtocontinuallyimprovetheirknowledgeandunderstandingoftheirjobrequirementsandtousethisinformationtoincreaseinsightastothescopefortheirresponsibilities. Jobdescriptionsalonecannotbeusedasanargumenttorefuseworkassignments.

    IncumbentSignature Date