drjobs ELN Business Analyst

ELN Business Analyst

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1 Vacancy
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Job Location drjobs

San Francisco, CA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

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.
  • Author 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.

Employment Type

Full-time

Company Industry

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