Quality Assurance And Compliance Manager
Current▪ Regulatory Compliance Management: Prepared and facilitated external inspections from regulatory bodies such as the FDA, DEA, CLIA, and state health departments, ensuring the laboratory complied with regulatory standards and maintained accurate and up-to-date compliance records, including documentation of audits, inspections, and certifications.▪ Internal Audits and Risk Assessment: Regularly conducted internal audits of laboratory practices to identify and address compliance risks or gaps, ensuring ongoing compliance through review and assessment of laboratory operations, protocols, and safety measures.▪ Protocol Development and Review: Developed, updated, and maintained laboratory protocols and procedures in alignment with regulatory and safety standards.▪ Staff Training and Education: Delivered ongoing training programs to a team of over 30 laboratory staff on compliance regulations, safety protocols, and quality assurance measures.▪ Collaboration with Regulatory Bodies: Served as a liaison between the laboratory and regulatory agencies, responding to inquiries, managing inspections, and ensuring proper documentation was available, in addition to collaborating with institutional review boards (IRB), animal care and use committees (IACUC), and biosafety committees (IBC) for research protocol approvals.▪ Quality Assurance and Improvement: Monitored laboratory performance and implemented measures for continuous improvement to meet compliance and safety standards.▪ Grant and Funding Compliance: Spearheaded the preparation of grant applications and proposals, securing over $500,000 in funding for research projects while ensuring adherence to compliance requirements in research settings.▪ Incident Reporting and Investigations: Oversaw the reporting and investigation of compliance breaches or safety incidents in the laboratory, implementing corrective actions and ensuring thorough documentation and resolution.
