Quality Assurance Associate Ii/Iii – Donor Eligibility & Suitability

ResponsibilitiesDonor Eligibility & Suitability ReviewPerform QA review of donor screening documentation for donor-derived starting materials, including donor medical history, behavioral risk assessment, and recovery documentationReview infectious disease testing results and laboratory reports to ensure compliance with regulatory donor eligibility requirementsVerify completion and accuracy of donor eligibility records including required testing, screening, and documentationAssess hemodilution evaluations, where applicable, to ensure validity and reliability of donor infectious disease testing resultsEnsure donor records meet applicable regulatory requirements under 21 CFR **** Subpart C and internal proceduresDocument donor suitability determinations and ensure proper QA approval prior to use of donor-derived materials in manufacturingEnsure donor eligibility determinations are completed prior to acceptance and use of donor-derived starting materials for manufacturingEnsure donor el...