Simplified and updated departmental policies and procedures, ensuring compliance to ISO 15189, CAP, CLIA, and other external regulations and directing changes in laboratory workflow where necessary.Managed quality items including inter-observer variability studies, interdepartmental case reviews, proficiency testing, and quality training, while focusing on improving the efficiency and reliability of workflows and assuring compliance to internal and external quality standards, communicating to management objectives, concerns, and redundancies.Prepared for and conducted various internal quality and compliance audits, including process, departmental, and pre-inspection assessments, and served as the Compliance Officer.Led monthly Quality Assurance meetings, communicating trends and progress to leadership and employees.Oversaw nonconforming event investigations. Evaluated root causes and determined corrective and preventive actions utilizing FMEA and Six Sigma tools. Developed and implemented a successful monitoring and reporting mechanism to analyze trends and overall CAPA effectiveness, communicating these findings to stakeholders.Designed and performed verification and validation of reporting systems and new clinical trial data management tools.Directed the student and pathology resident program, resulting in a significantly more meaningful and relevant experience according to student, resident, and employee surveys. Developed the pathology quality indicators report to effectively communicate current and emergent issues as well as track improvements in workflows, deriving data from custom reports.Represented the Pathology Department for the Clinical Trials program providing financial analysis for new and existing projects while developing and executing customized data transfer contracts and agreements with CROs.

Presented a Master Class at the 2017 Executive War College in New Orleans, describing in detail the ISO 15189 accreditation process and its benefits to the laboratory.Hosted audits and inspections for current & prospective clinical trial clients, governing bodies, and accrediting agencies, including FDA, CAP, CLIA, A2LA, and NYSDOH, and prepared follow-up documentation addressing findings with nonconformance investigations and corrective and preventive actions. Designed, validated, and implemented an automated reporting system.Created new and updated existing standard operating procedures while establishing and maintaining a compliant electronic document control system. Created and executed a Risk Assessment program to anticipate and communicate potential areas of concern and address and implement requirements of an ISO 15189 accreditation.Fostered relationships between departments, executives, and outside auditors & clients by demonstrating effective communication, positive disposition, and patience & tact centered on the common goal of ever improving excellence and economy of operations.Developed and implemented the Software Quality Assurance Program during the development of a new laboratory information system, currently in use. Established effective communication and agreement between users, leadership, and the software development team by implementing weekly design review meetings.Conceived and created the Information Technology Software Development Policy to reduce errors and improve efficiency by analyzing and refining user input and designing a system to collect, categorize, and communicate these requirements to Software Development.Acted as the liaison between executives and software developers to assure that quality, accountability, and productivity was paramount in the planning, coding, verification, validation, and implementation of a new Laboratory Information System. Provided guidance on UI/UX for the Laboratory Information System.

Performed Fluorescence In Situ Hybridization (FISH) setup, processing, and analysis (manual and automated) of hematological and paraffin embedded tissues using enumeration, translocation, and break apart probes.Ensured a high level of accuracy and quality by generating clinical reports and working in close cooperation with directors, pathologists, and the cytogenetics team to address any concerns in methods or training.Began developing quality measures and recommendations to reduce errors and improve throughput by documenting and analyzing potential error paths and in vitro diagnostics process deviations.Worked in unison with the director, supervisor and cytogenetics team to ensure that the laboratory met quality and safety guidelines set forth by CAP and other regulating agencies.

Performed sample setup, harvest, slide preparation, and microscopy of chromosomes from cultivated peripheral blood leukocytes. Trained new and existing employees with a focus on positive feedback and attention to detail.Displayed leadership and responsibility by managing specialized Fanconi’s Anemia testing.Planned the test phase operation of HANABI PI Automatic Harvester and participated in writing the SOP.