Quality Assurance Associate II/III – Donor Eligibility & Suitability
Scorpion Therapeutics • estado de méxico, Mexico
Role Description
Responsibilities Donor Eligibility & Suitability Review
- Perform QA review of donor screening documentation for donor-derived starting materials, including donor medical history, behavioral risk assessment, and recovery documentation
- Review infectious disease testing results and laboratory reports to ensure compliance with regulatory donor eligibility requirements
- Verify completion and accuracy of donor eligibility records including required testing, screening, and documentation
- Assess hemodilution evaluations, where applicable, to ensure validity and reliability of donor infectious disease testing results
- Ensure donor records meet applicable regulatory requirements under 21 CFR 1271 Subpart C and internal procedures
- Document donor suitability determinations and ensure proper QA approval prior to use of donor-derived materials in manufacturing
- Ensure donor eligibility determinations are completed prior to accept...