AstraZeneca Pharmaceuticals LP Quality Assurance Specialist II in Philadelphia, Pennsylvania

The Quality Assurance Specialist II is responsibleforQAactivitiesthatdirectlysupportexecutionoftheprocessbothwithintheProcessExecutionTeam(PET) and inassignedareasoutsideofthePETs.Theseactivitiesmayincludebutarenotlimitedto:batchrecord review,changecontrol anddocumentation,equipmentandprocessvalidation, deviationinvestigations,SOPs,,distribution centermanagement, internal inspectionsandregulatory interactions.

Responsibilities include but are not limited to:

  • Maintainsahighlevelofunderstandingofrelevantproductionprocessesandqualitysystems

  • PerformstheQAreviewandapprovalofthefollowingGMPdocumentationasitrelatestotheprocessingequipment andfacilitytowhichthepositionisaligned:

    oChangeRequests oBatchRecordsandassociateddocumentation o ProductandComponentReleasetransactionsinSAP oQualityInvestigations(Deviations,ProductComplaints) oValidationPlans,ProtocolsandReports oStandardOperatingProcedures
  • CollaborateswithandinfluencesotherQualityprofessionalsacrosstheorganizationtoensureconsistentapplication andexecutionofkeyqualitysystems

  • ExecutesQAprocessesincludingbatchrecordreview,productdispositionandqualityissueresolutiontomaintain theflowofproductsanddocumentstomeetsiteobjectives

  • Workswithapplicablesitesupportgroupsonprojects(capitalandnon-capital)thatimpactthePET/assignedarea,and proactivelyensuresGMPcomplianceduringtheplanning,executionandcloseoutphasesoftheseprojects

  • CollaborateswithandinfluencesotherPET/assignedareamemberstofacilitateprocessimprovementsandrisk assessments;benchmarksinternalandexternalQApracticestoidentifyinnovativeefficientandeffectivepractices

  • Staysabreastofevolvingregulatorycompliancepracticesandrecommendsimplementationstrategiestositeleaders

  • Collaboratesindataanalysisandreportcreationonqualitymetricsandkeyperformanceindicators

Qualifications:

Education:

+ Bachelors degree in a Science / technical field such as Pharmacy, Biology, Chemistry or Engineering or any Bachelors degree.

Required:

  • Minimum of three (3) years' experience in the pharmaceuticalindustry inrolescoveredbyGMP oversight.

  • Strong ability and motivation to learn.