AQC Testing Analyst II

Job Overview

Seeking an Analyst II for AQC Testing to perform quality control testing for CSI samples in clinical trials. This role involves coordinating with internal and external hubs, CROs, and partners, and ensuring compliance with SOPs and regulations.

Responsibilities

• Perform/assist QC testing for CSI samples
• Drive COA issuance for hubs
• Liaise with CROs/external partners for testing reports
• Escalate OOS results and resolve deviations
• Support SOPs, QA, and documentation workflows
• Provide method verification support and train staff

Requirements & Qualifications

• BSc in Life Sciences with 2+ yrs or MSc with 0+ yrs
• GMP and GDP knowledge preferred
• Endotoxin, Sterility, pH, Osmolality methods knowledge
• Experience in cell therapy and pluripotent stem cells
• Excellent written and oral communication skills
• Highly organized and flexible with changing priorities