Profile Summary Sixteen year Quality improvement, process implementation and project management professional, with a Master's of Science in Management, and a Bachelors of Arts in Biology. Expert in regulatory and compliance, quality and business process design, and business process integration. Strong leadership abilities and years of experience in project management and supervision. Regulation Experience and/or familiarity 21 CFR 210 & 211 21CFR 803, 807, 809, 812, 820, 21 CFR 600-640 21 CFR 1271 (Pharmaceutical) 862, 864, 866 (Biologics) (Tissue) (Medical Device - IVD) 42 CFR 493 NYS Section 79-L, Article 5, Title Accreditation: Logical Observation Identifiers (Clinical Laboratory) V, Title 10, NYCRR Part 19 & 58 The Joint Commission Names and Codes (Clinical Laboratory) AABB Meaningful Use National Laboratory Test Registry CAP 21 CFR 11 21 CFR 50, 56, 201, 312 Clinical Trials Monitoring Branch ISO Electronic Records Electronic Clinical Trials Audit Guidelines 9001, 15189 Signatures ClinicalTrials.gov registry CTRP registry Summary Sixteen year Quality improvement, process implementation and project management professional, with a Master's of Science in Management, and a Bachelors of Arts in Biology. Expert in regulatory and compliance, quality and business process design, and business process integration. Strong leadership abilities and years of experience in project management and supervision. Regulation Experience and/or familiarity 21 CFR 210 & 211 21CFR 803, 807, 809, 812, 820, 21 CFR 600-640 21 CFR 1271 (Pharmaceutical) 862, 864, 866 (Biologics) (Tissue) (Medical Device - IVD) 42 CFR 493 NYS Section 79-L, Article 5, Title Accreditation: Logical Observation Identifiers (Clinical Laboratory) V, Title 10, NYCRR Part 19 & 58 The Joint Commission Names and Codes (Clinical Laboratory) AABB Meaningful Use National Laboratory Test Registry CAP 21 CFR 11 21 CFR 50, 56, 201, 312 Clinical Trials Monitoring Branch ISO Electronic Records Electronic Clinical Trials Audit Guidelines 9001, 15189 Signatures ClinicalTrials.gov registry CTRP registry

Highlights:

• Management
• Billing
• Compliance
• Laboratory Work
• Leadership
• Pathology
• Inventory
• Cancer
• Inventory management
• ISO