Data Processing - Cognition Specialist

The purpose of this job is to serve as a Documentation Analyst, specializing in Cognition to work to the highest standards in terms of quality and professionalism.

Job Responsibilities

• Stability data reporting for regulatory filings (IND, BLA). Perform date review as required.
• Updates to Shelf-life memos and Annual stability reports.
• Support stability lead in BLA preparation (batch analysis and justification of specifications).
• Work with the Cognition Cockpit global support team to resolve any issues with the system.
• Implement continuous developments and enhancements to the Cognition Cockpit system.
• Keep up to date with existing and new SOP’s and official documentation.
• Perform other duties as designated by Management.
• Independently write/revise SOP’s or other official documentation and reports, when required.
• Execute independently assigned projects.

Requirements

• A Bachelor Degree or Master Qualification in Chemistry, Biology or a related field with knowledge of analytics and/ or stability.
• At least 2-3 years of industry experience
• Mathematical and/or analytical preference
• Practical analytical laboratory experience in a GMP environment is preferred ...