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Senior Business System Analyst with QMS/Pharma

Foster City, CA
Quality Management System - Senior Business Analyst  

Type of role: Contract
Duration: 12+ months
Hourly pay rate: DOE (C2C, W2, or 1099 permissible)
Location: San Francisco Bay area (*partial remote may be allowed)

Our customer is seeking a senior level Quality Management System (QMS) Business Analyst who is well versed in GxP processes within a FDA regulated / Pharmaceutical or Biotech environment.
They are undergoing a Quality Management System technology assessment. Consultant will be instrumental in mapping out business processes and building a business process catalog which forms to their BPM methodology
Job Description:
  • Understand and Identify business processes and improvements for QMS domain in a GMP environment
  • Must have previous experience with new QMS solutions (i.e. Trackwise, Veeva, Master Control)
  • 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
  • Review and estimate change requests
  • 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
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