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LIMS Business Analyst / Pharma

Foster City, CA · Biotech/Pharmaceutical
Labware LIMS System Business Analyst / CSV  Pharma

Type of role: Contract
Duration: 12-36+ months 
Start date: January 7, 2020
Hourly pay rate: DOE (C2C, W2, or 1099 permissible)
Location: Foster City, CA 94404

Our client in Foster City is seeking a senior level Business Analyst skilled in Labware LIMS and GxP processes within a FDA regulated / Pharmaceutical environment. This person should be an expert in LIMS processes from the business side and the validation side and should also be experienced in pharmaceutical validation processes.

Job Description:
  • Understand and Identify business processes and improvements for Labware LIMS domain in a GMP environment
  • Must have previous experience with new Labware LIMS solutions  
  • Ability to implement business process improvements with stakeholders
  • Create use cases
  • Create high quality user and functional requirements
  • Analyze requirements to determine priority and business value
  • Create required regulatory and SDLC documentation
  • Collect information regarding and monitor progress of business analysis activities
  • Create as-is and to-be process maps and narratives
  • Create requirements traceability matrices
  • Provide estimates for workstream activities, including dependencies, to the Project Manager
  • Identify, manage and resolve risks and issues related to the workstream
  • Provide Project Manager with status updates, activity progress and schedule updates
  • Maintain excellent client relationships
  • Contribute to all areas of system implementation including but not limited to vendor interaction, system compatibility, change control, qualification, deployment, and training
  • Work with project teams to ensure compliance with regulatory requirements such as FDA, CAPA, GxP as well as internal policies and processes
  • Excellent organizational, written, verbal communications skills
 
 
Dawn West
AdeptSource
 
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