Related skills
gmp sop cgmp cell therapy gdp📋 Description
- Perform/assist QC testing for CSI samples for clinical trials
- Drive COA issuance for internal and external hubs per SOPs
- Liaise with CROs/external partners for testing reports
- Escalate OOS results; coordinate with teams to resolve deviations
- Support SOPs, QA, and documentation workflows for QC testing
- Provide method verification support and train QC staff
🎯 Requirements
- BSc in Life Sciences with 2+ yrs or MSc with 0+ yrs in relevant field
- GMP and GDP knowledge preferred
- Endotoxin, Sterility, pH, Osmolality methods knowledge
- Experience in cell therapy and pluripotent stem cells
- Excellent written and oral communication; highly organized
- Flexible; able to adapt to changing priorities and schedules
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