- Perform 3rd party Audits to ensure constant state of compliance. - Perform 3rd party Inspections for accreditation readiness. Documented compliance gaps, recommended corrective and preventive actions, created or updated documents, and improved existing Quality Management Systems. - Subject Matter Expert in government audits for laboratories.- Advised and led implementation efforts for laboratories on an effective Corporate Compliance program, including hotline implementation, Board of Director training, physician education and drafting of agreements.- Research and interpretation of laws, statutes, and requirements.- Assessment of laboratories Corporate Compliance programs based on OIG and DOJ guidance.

-Served as Strategic Advisor and Leader for regulatory compliance, information management, and lab operations. -Advised and served as Subject Matter Expert in government audits and investigatory demands. -Designed and implemented Bridge’s Corporate Compliance Program, including Compliance Helpline & Incident Management systems, sanctions screening process, and Bridge’s Corporate Compliance and HIPAA Privacy Manuals. -Designed and implemented Bridge’s Audit & Monitoring program, including monitoring of supplies & equipment, employee attestations & training, sanctions, agreements and HIPAA Privacy. -Designed and implemented a Compliance Survey and Exit Interview in measuring the effectiveness of Bridge’s Compliance Program. -Led efforts on implementation of Bridge’s Code of Conduct. -Drafted and reviewed client and vendor contracts in collaboration with outside counsel. -Interpreted healthcare related laws, statutes, and requirements. -Advised on Bridge’s Quality Management System for Bridge’s Irvine location. -Led and coached Bridge’s Quality and Compliance teams, consisting of 3 team members. -Designed and implemented CLIA, CAP, and healthcare compliance training for various departments. -Partnered and served as an advisor to Billing, Sales, Client Services, Field Operations, and HR leadership on compliance matters.

-Served as Strategic Advisor and Leader for regulatory compliance, informationmanagement, lab operations and automation.-Advised and served as Subject Matter Expert in government audits andinvestigatory demands.-Designed and implemented a Compliance Survey and Exit Interview inmeasuring the effectiveness of Precision’s Compliance Program.-Developed and implemented automated audit and monitoring for Precision’s“high-risk” clients.-Led efforts on implementation of a compliance Risk dashboard in PowerBI.-Led efforts on implementation of an authorized provider check by partneringwith Precision’s Client Services team.-Led efforts on implementation of a provider PECOS check by partnering withPrecision’s Billing team.-Served as Subject Matter Expert in review of Marketing Material.-Served as reviewer for CERT audit submissions.-Partnered with Precision Billing team and implemented a quarterly MedicalNecessity audit.-Developed and implemented Test Utilization using OIG guidelines.-Led and coached Precision’s Quality and Compliance teams, consisting of 6team members.-Served as certified OKR coach for Quality, Compliance, Client Services and HRdepartments.-Led OKR creation and execution for 6 consecutive quarters.-Improved data analysis for common quality assurance indicators.-Managed CLIA, CAP, and healthcare compliance training for new hires.-Managed internal inspections for accreditation and state agencies.-Managed internal inspections for Precision’s additional lab divisions inMassachusetts, Connecticut, and Michigan.-Maintained a zero-deficiency score for CAP and NY DOH external inspections.

-Led implementation of a new Document, Training, Inspection, and IncidentManagement System.-Led and coached Precision’s Quality team, consisting of 3 team members.-Direct participation in hosting regulatory agency inspections.-Direct participation in internal inspections for accreditation and state agencies.-Developed and implemented Quality Management Systems for additional lab divisions in Massachusetts, Connecticut, and Michigan.-Designed and implemented CAP and FDA compliant validation protocols forClinical Laboratory LIMS and data analysis modules.-Managed Precision’s Safety Program, including employee training, maintenanceof policies and procedures, and participation in internal and external inspections.-Partnered with Precision's Chief Compliance Officer on various corporate compliance process improvement projects, including medical necessity audits and Sales education and training.

-Served as HIPAA Privacy Officer.-Developed and implemented Precision's Quality Management System for the San Diego location.-Direct participation and management of preparation for various agency inspections, including COLA, CAP, and state of CA.-Partnered with leadership on quality measures within laboratory operations.

*Overseeing development and implementation of new lab procedures and processes.*Direct preparation and participation in regulatory agency accreditation and inspections.*Maintaining and improving the Quality System and Procedures.*Maintenance of Chemistry analyzers.*Standard, control, and reagent preparation.*Participation in reorganizing inventory and data analysis system.

-Supervise multiple staff in pre-analytical and analytical sections of laboratory.-Manage time clock system and perform development reviews.-Design and implementation of a process to minimize instrument run time and require less FTE.-Spearheading implementation of new testing platform.-Manage and review instrument validations, maintenance logs, and SOP revisions.

· Completion of a Green Belt project of the first reagent database used at Quest Diagnostics, with email notifications when a reagent is about to expire, and monitoring of reagent inventory. · Extraction and detection of various metabolic disorders using LCMS and Agilent Chemstation system. · Knowledge in processing and filing Amino Acids Aciduria reports. · Maintenance and troubleshooting of LCMS. · Standard, control, and reagent preparation and evaluation for Amino Acids. · Knowledgeable in creating and editing methods for Agilent Chemstation system. · Participation in set up and evaluation studies in Amino Acids. · Protocol preparation, maintenance of Quality Control documentation, and accurate filing of high volume assays. · Additional duties such as SOP revisions, training of employees, organization of benches, and testing of proficiency samples.

· Completion of Green Belt project 'Reduction of Acylcarnitines set-up time', reducing set up time by two hours. · Extraction and detection of various metabolic disorders using Janus and Multiprobe automated pipetting stations, LCMSMS, and MassLynx and Xcalibur systems. · Extraction and detection of porphyrias using Waters HPLC and Empower system. · Knowledge in processing of quantitative Organic and Amino Acidurias. · Maintenance and troubleshooting of HPLC, LCMSMS, Janus, and Multiprobe, with knowledge of minor maintenance of GCMS and LCMS. · Standard, control, and reagent preparation and evaluation for Acylcarnitines. · Knowledgeable in creating projects and methods for Xcalibur and MassLynx software. · Protocol preparation, maintenance of Quality Control documentation, and accurate filing of high volume assays. · Additional duties such as training of employees, organization of benches, and testing of proficiency samples.

· Proficient in automated methods such as AXSYM and Olympus AU 640. · Extraction of porphyrias using Waters HPLC and Empower System. · Safety Officer responsible for maintaining safety in the laboratory. · Work in a team environment and under time constraints. · Comply with QA and Health and Safety policies.

· Several methods used for solid-liquid and liquid-liquid extraction for Pesticide, Diesel, chlorinated hydrocarbons, and Oil and Grease analysis. · Standard preparation and IR analysis for Oil and Grease samples. · Carry out detailed preparation according to published analytical methods and SOP's.