About
A highly ethical and adaptable Quality Assurance (QA) professional, experience in varied pharmaceutical settings. Experience includes coordination of Immunoglobulin (IVIG) home infusion services and Specialized Pharmacy Services addressing the needs of Hemophilia, Neurological Disorders, and Immune-Deficiency Communities. Several years of QA experience conducting internal corporate audits, remote and on-site Interim Monitoring Visits (IMV), and for cause audits of oncology, vaccine, and infectious disease research studies. Conduct audits of electronic Trial Master File (eTMF) in accordance with site Sponsor SOP and ICH/GCP guidelines. QA experience includes managing operations at a plasma donor center and ensuring compliance with GMP and GLP specifications. Conduct international and domestic GCP compliance audits.
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