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Amy Wotawa

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I help pharma and biotech organizations reach their goals beyond just checking the compliance box with a broad range of GxP Quality Assurance and Regulatory Compliance Management experience. My technical focus is primarily GLP/GCLP: -Audits/vendor qualifications -Gap analysis -Quality Assurance consulting -Quality Management System (QMS) design/support/remediation -Corrective and preventive action (CAPA) support Examples of therapeutic areas and discipline expertise include: -Oncology -Cytogenetics/FISH -Immunology -Immunohistochemistry -Pathology -Histopathology -Flow Cytometry -Molecular Genetics/NGS -Toxicology -Biomarkers SIGNATURE STRENGTHS: ► Internal/External Audits ► Quality Management Systems ► Vendor Management ► Project Management ► Policy & Procedure Development/Implementation ► Corrective and Preventive Actions ► Training Development/Delivery ► Process Improvement Activities ► Cross-functional Communicator/Advisor/Liaison CONNECT with me here on LinkedIn

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