ELN Business Analyst Job at Katalyst CRO in San Francisco

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We are seeking a qualified candidate to lead business analysis and training activities for ELN/LIMS-related projects within Biotechnology and Pharmaceutical environments.

Overview

Position: ELN Business Analyst — Katalyst CRO

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.
• Review and assist in the preparation of technical documentation including Change Management Records, Design Specifications, Configuration Specifications, Validation Protocols, Validation Reports, and other Computer System Validation documentation.
• Coordinate with business users on review and updates to requirement specifications and user acceptance tests.
• Coordinate with cross-functional stakeholders such as System Manager, QA, Business Process Owners and End users.
• Maintain regular communications with business to address changes to plans and 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 a 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

• Associate

Employment type

• Contract

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing