Title: ELN BIOVIA Business Analyst/Trainer

Location: Foster City, CA

Duration: 12+ Months

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 trainings, live demos on current business processes and system changes to end user community.


• Create training materials for in-person, web-based video, document read & understand trainings.


• 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.

Skills:

• 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 in required


• Must have experience as a trainer


• Experience in ELN systems such as BIOVIA Workbook, IDBS Biobook, CambridgeSoft E-Notebook, VelQuest SmartLab 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