Building on current GxP knowledge and acquiring CPHQ certification

•SME for clinical and pharmaceutical processes of CAP, COLA, NYSDOH, CMS,21 CFR 820, OSHA, NJDEP, and NJDOH regulations for the Hicksville, NY, and Monmouth Junction, NJ laboratory locations. • Created a QMS; building a new department. Mentored staff in QA. Processes included but were not limited to the creation and enforcement of policies and procedures and quality monitors, change management, CAPA creation, and investigations, root cause analysis), risk assessments, internal audits, and document control.• Ensured inspection readiness. Prepared for/passed NYSDOH and COLA audits.

• Directed quality assurance operations by serving as an SME for GMP, FDA, and ISO regulations for manufacturing operations of PET and Diagnostic Therapy Departments (FDA 21 CFR parts 210, 211, and 212 standards). • Reviewed quality control, batch records, CoAs, system maintenance, and environmental monitoring (ISO 5 and 7/aseptic monitoring) to ensure they were within specifications. • Conducted internal and external audits, addressed non-conformances, created quality goals and KPIs, and resolved stakeholder issues. • Devised and implemented a new, complete QMS.• Created MedWatch, answered, and monitored all FDA recalls.• Point person for all regulatory agencies-.

• Orchestrated QMS within the TQM framework for all laboratories and point-of-care sites. Company-wide SME and representative for all regulatory agencies, internal/external/3rd party vendors audits, errors, and complaint investigations.• Redefined the QMS by creating and enforcing a high-level FDA, CLIA, and state-compliant corporate quality manual to cover all clinical sites. • Formalized core processes and mentored staff in QA processes• Guided the implementation and adherence of FDA 21 CFR parts 820 and 11 standards, NYS, CLIA, CDC, ISO 15189 regulations (CAP) to meet regulatory standards and “right the first time" deliverables.• Approved FDA validations (21CFR Part 11), document control (MasterControl), Pathologist-approved LDT validations, SOPs, and QC.• Defined, monitored, and performed trend analyses, quality goals, and KPIs on revised reports, and non-conforming events/products to ensure continuous quality improvement.o Decreased non-conforming events and products/CAPAs by 8% in 2020 via process changes and inter and intra-departmental team education. o Increased CAP survey correct results by 4% from 95% to 99% for three years with the restructuring of Quality's proficiency testing process. o Decreased revised patient reports by 7%. • Partnered with OPKO on a drug PMA.• Authored and reviewed quality and lab administration (Ethics and HR) SOPs, validations, and training materials for use across national laboratory operations. • Restructure of credentialing process for all technical personnel.• Directed review and inspection readiness of all BioReference laboratories and its subsidiaries for all regulatory agencies: NYS, CMS, CAP, COLA, FDA (laboratory and medical devices), AABB, OSHA, NJDEP, EPA, Massachusetts DOH, Nevada, DOH. • Supervised twenty-five direct reports and multiple indirect reports.

• Authored and implemented SOPs and policies, and defined KPIs, for pathology, clinical laboratory, morgue, and animal research operations.• Utilized Six Sigma to cut waste.• Addressed non-conformances and FDA recalls.• Decreased the laboratory budget 5% by creating a zero-based budget and restructuring vendor contracts.• Achieved a 30% decrease in ER Stroke testing to twenty minutes. • Boosted laboratory productivity by 8% to 97% through staff optimization and a new document control system. • Supervised 145 direct and indirect reports.• Ensured inspection readiness: NYS (CMS), CAP, EPA, DEA, USDA, FDA, TJC.

• Developed and implemented anatomic and clinical policies and procedures ensuring adherence to quality standards.• Optimized resources to drive change and execute strategic plans by running interdepartmental team meetings for employees and contractors. • Coordinated laboratory training for the School of Medical Technology and incoming medical students and residents. • Addressed FDA recalls. • Core member of interdepartmental teams: Joint Commission Prep., Infection Control, Safety, Environment of Care, Emergency Preparedness, Revenue Management, Value Analysis, and Performance Improvement.• Reduced non-conforming events by 5% by instituting CQI and corrective and preventive actions (CAPA). • Delivered $429K+ cost avoidance and $100K+ cost savings in the blood bank/blood donor area.• Developed and managed laboratory outreach increased revenue by $1.5M. • Responsible for inspection readiness: NYS (CMS), AABB, TJC, OSHA, FDNY• Supervised 125 direct and indirect reports.

• Managed operations in the clinical laboratory (96 direct reports) including outreach.• Championed Six Sigma process improvements and the coordination of resources to reduce laboratory costs resulting in:o 8% decrease emergency room wait time by 41%.o STAT laboratory test turnaround time by 41%.o Telemetry discharge times related to laboratory test processing 72%. o Laboratory testing turnaround time 56%.o 40% increase in outpatient volume. • Coached and mentored managers to ensure continuous quality improvements. • Responsible for inspection readiness: Leapfrog, TJC, CAP, AABB.

• Supervised 19 direct reports in all laboratory services: transfer in phase II materials, solvent disposal etc.• Identify/implement cost improvement proposals and change initiatives.• SOP creation, approvals, and enforcement involving cGMP/cGLP, OSHA, and other applicable regulations, and safety standards. Point person for Lean Six Sigma projects. • Created a library exchange, and inventory management system for small instrumentation and reusable glassware for research, saving $1M annually.• Conducted a safety Six Sigma project resulting in a 7% decrease in employee accidents. • Implemented Six Sigma facilities optimization project that organizational structure of the Merck, Rahway site assigning jobs to the lowest cost provider.

• Established laboratory services for physician offices, dialysis units, and nursing homes increasing Outpatient testing volume by 400% in the first year of operation• Developed, directed, and participated in cross-functional TQM (Total Quality Management) teams and PDCA (Plan, Do, Check, Act) projects.• Composed and implemented policies, procedures, QA audits, PI projects, and continuing education programs for technical, supervisory, and clerical employees.• Monitored hospital point-of-care testing.• Mentored radiology, medical technology and medical students, nursing staff, and new employees in laboratory science. Mentored clerical staff on registration systems.• Responsible for all regulatory audits. The laboratory was inspection-ready at all times.

• Redesigned a new laboratory, maximizing the space which translated to a 33% increase in lab services• Increased outpatient volume 23% by marketing laboratory to physicians and assisted living centers.• Decreased operating budget by 5% annually for 9 consecutive years. • Mentored medical technology students, and laboratory personnel in laboratory medicine. • Chaired monthly interdisciplinary team and departmental meetings • Enhanced the blood bank by instituting and validating a new system and upgrading test methodologies.• Monitored hospital Point of Care testing. .• Responsible for ensuring that the laboratory was inspection ready at all times