Manager of Quality Assurance for Diagnostics and Countermeasures Branch (DCB), Center for Infectious Disease Research (CIDR), Walter Reed Army Institute of Research (WRAIR)

Ensure laboratory compliance with all applicable regulatory requirements including CAP, State of New York Department of Health, CLIA/OSHA, etc. through inspections, audits, and development of internal processes and procedures. Establish critical complex projects to determine areas of improvement by identifying root causes and developing high impact, and long lasting workable solutions. Provide leadership with respect to patient safety, testing quality, laboratory test utilization, and operational performance. Implement process control by utilizing and employing quality system essentials to produce desired outcomes. Improve the efficiency of laboratory processes by statistical analysis of data (i.e. batch records) to report trends at all stages of sample processing reducing repeat rate, decreasing turn-around time, reducing costs, decreasing the rate of reported non-conformance events, and improving overall success. Widely recognized by management for superior performance in ensuring compliance and ability for creative problem solving.

• Work with Quality systems to identify and interpret regulations, guidelines, and checklists that contain pertinent information issued by Gold Standard regulatory organizations such as CAP, NYS, CLIA, and OSHA.• Organize and conduct various QA/QC specialized trainings with Directors, MD/PHD fellows from NIH, and fellow Core team members (Technicians/Supervisors/etc).• Identify needed process improvements through maintaining and generating effective quality assurance monitoring tools such as Robotic Failure rates, Corrective Action Trends, Contamination, Turn-Around Time (TAT). • Driving policies and quality program initiatives based on proven methodology with evidence and supporting documentation. • Create, modify, and review Standard Operating Procedures, Validations of reagents/software/equipment/workflow, document control items such as TOC/Reagent Logs/Solution Logs/, etc.

• Lead responsibilities of various laboratory tasks including inventory, solution preparation, rearrangement of PCR product through use of Hamilton Robots, Sanger dideoxy chain termination method of sequencing, and performance of Heteroduplex/Digest analysis of rare genetic hereditary diseases. • Performed full gene sequencing tests to detect germline mutations that may be present in any exon or splice site of that gene, without limitations to previously published high frequency reported mutations. • Determined if sequences for analysis met the read length, trace score, and signal strength quality criteria described in Sanger sequencing. • Trained technicians on test methods and overall lab operations.

• Generated concise and accurate queries detailing non-public information for the use of the Administrator of Corporate Security and Facilities at Fannie Mae. • Researched and presented to policy makers advanced methods and procedures for the human resources department.