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ELN Business Analyst

ELN Business Analyst

Katalyst Healthcares and Life SciencesSan Francisco, CA, United States
19 hours ago
Job type
  • Full-time
Job description

Responsibilities :

  • Work closely with the project team and end-users through the full software life cycle of system scoping, requirements gathering, technical specifications, change control, qualification, deployment, and training.
  • Provide in-person and online training, live demos on current business processes and system changes to end user community.
  • Create training materials for in-person, web-based video, and document-based training.
  • Create detailed business analysis, use cases, outlining problems, process maps, finding opportunities and solutions for improvement, including communicating recommendations as well as technical challenges.
  • uthor and update technical documentation including SOPs, Work Instructions, and User Manuals.
  • Contribute and assist in review of technical documentation including Change Management Records, Design Specifications, Configuration Specifications, Validation Protocols, Validation Reports, and other Computer System Validation documentation.
  • Co-ordinate with business users on review and updates to requirement specifications, user acceptance tests.
  • Co-ordinate with cross-functional stakeholders such as System Manager, QA, Business Process Owners and End users etc.
  • Maintain regular communications with business, to address changes to plans / schedules.

Requirements :

  • Experience working in Biotechnology and Pharmaceutical laboratories for R&D or QC testing.
  • Good understanding of Drug Development and QC processes.
  • Experience as business analyst for Laboratory Informatics systems such as LIMS, ELN, LES, CDS systems.
  • Must have experience as a trainer.
  • Experience in ELN systems such as BIOVIA Workbook, IDBS Bio book, Cambridge Soft E-Notebook, Values Smart Lab is beneficial.
  • Strong understanding of GxP regulations governing computer system validation and operations in biopharma industry. Strong communication / interpersonal skills, technical writing, analytical and problem-solving skills.
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    Analyst • San Francisco, CA, United States

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