Job Details

Join to apply for the ELN Business Analyst role at Katalyst CRO.

This position involves working closely with project teams and end-users throughout the entire software lifecycle, including system scoping, requirements gathering, technical specifications, change control, qualification, deployment, and training.

Key responsibilities include providing in-person and online training, creating training materials, developing detailed business analysis and use cases, authoring and updating technical documentation such as SOPs and User Manuals, reviewing validation and change management documentation, coordinating with stakeholders on requirement specifications and user acceptance testing, and maintaining communication with the business regarding project updates.

Requirements:

• Experience in Biotechnology and Pharmaceutical laboratories, particularly in R&D or QC testing.
• Understanding of Drug Development and QC processes.
• Experience as a business analyst for Laboratory Informatics systems like LIMS, ELN, LES, CDS.
• Proven experience as a trainer.
• Knowledge of ELN systems such as BIOVIA Workbook, IDBS BioBook, Cambridge Soft E-Notebook, Values Smart Lab is advantageous.
• Strong understanding of GxP regulations governing computer system validation in the biopharma industry, along with excellent communication, technical writing, analytical, and problem-solving skills.

Additional Details:

• Seniority level: Associate
• Employment type: Contract
• Job functions include Research, Analysis, and Information Technology
• Industry: Pharmaceutical Manufacturing

This job posting appears to be active, as there are recent listings and no indications of expiration.