Katalyst CRO is hiring: ELN Business Analyst in San Francisco

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.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

Industries

• Accounting and Business Consulting and Services