* Deviation management and CAPA implementation * Ensure center compliance to FDA/GHA regulations and various regulatory agencies * Conduct periodic observations and MSQRs * Prepared/assisted various plasma centers country-wide for internal and external audits (FDA, GHA etc.) * Risk analysis/mitigation and root cause analysis of errors that pose significant risk * Implement SOP changes in the donor center * QA review and release of softgoods and supplies for production use * QA release of collected plasma units * QA release of SPE and VMT samples * Submission of periodic Proficiency testing/QA review of CLIA personnel. * QA review of equipment received/transferred and equipment incidents * Applied lookbacks/destruction of unsuitable plasma units * QA review of VMT notifications and UTRTL Issues * Well-understanding of cGMPs and Good Documentation Practices * Employee counseling and error remediation of minor/major deviations * Maintain/update Controlled Documents * Document retention of calibration certificates, certificate of sterility and IQ/PQ/OQ