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Reference # : 18-38421 Title : Serialization Business Systems Analyst
Location : San Dimas, CA
Experience Level : Start Date : 07/09/2018  

  • Under the guidance of System Manager develop software life cycle documents such as: User Requirements, Functional Design Specifications, Test protocols, Computer System Assessments etc.
  • Under the guidance of System Manager execute SAT and commissioning protocols
  • Assist System Manager and corporate IT team during various stages of integration testing
  • Assist System Manager with System backup and restore testing
  • Under the guidance of System Manager develop User Manuals & Standard Operating Procedures (SOPs)
  • Assist local and corporate validation team in developing and executing validation protocols
Knowledge, Experience and Skills
  • 3+ yrs experience as a Business Systems Analyst in a regulated life sciences environment (Required)
  • 2+ yrs experience with implementing Serialization systems (Required)
  • 3+ yrs experience developing life cycle documents such as: URS , Functional Design Specs , Technical Design Specs , Test Scripts , Computer System Assessments (Required)
  • 3+ yrs experience with EU Annex 11 , 21CFRPart11 , GAMP5 as it relates to GxP computerized systems (Required)
  • Familiarity with - SQL Server 2012 cluster , Web Services , XML , Windows Server 2012  (Required)
  • Experience with Systech Serialization Systems (Desired)
Experience with using Documentum & Valgenesis (Desired)