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Business Analyst - Serialization
Ref No.: 18-00353
Location: San Dimas, California
Position Type:Contract
Experience Level: 8 Years
Start Date: 07/23/2018
Role: Serialization Business Analyst for a contract position in San Dimas, CA.
Location: Preferably based in CA San Dimas/ La Verne to help on an upgrade project.

Essential Duties and Job Functions

• 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 (Mandatory)

• Experience with using Documentum & Valgenesis (Desired)