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...