Leck Intharath Email & Phone Number

San Diego, Ca, Us

Carlsbad, California, United States

SUMMARYThis position is responsible for GMP compliance of the facility. Supports in the management, oversight, & timely closure of the Nonconformance reports, Corrective and Preventive Actions, and Deviations. Represents Quality Assurance & interacts with cross-functional departments to provide quality guidance.Ensure compliance with all relevant quality management system and regulatory requirements (e.g., ISO 13485, 21 CFR 820).Assist as a backup to the change control processes to ensure standardization, accuracy, & completeness of documents prior to release.Stakeholder in the development, implementation, and continued improvement of quality systems within the QA department.ESSENTIAL DUTIES & RESPONSIBILITIES• Provides QA oversight and timely closure of NCRs, Deviations & CAPAs. • Supports in GMP investigations & Audits.• Provides QA guidance to staff and training on quality system requirements.• Conducts information gathering sessions with cross-functional departments to obtain required information & data to complete investigations.• Assess & document product impact within investigations.• Conduct root cause analysis & document within the investigation including causal factors identified & any root causes determined.• Based on root cause outcome, identify & initiate appropriate corrective actions (CAPAs).• Complete accurate & thorough historical searches within quality system database to identify any similar events and determine if a trend exists or is developing.• Create clear, concise investigations with appropriate details.• Own CAPAs & provide project management oversight of the CAPAs to ensure all required corrective actions remain on track and are closed by assigned due dates.• Participation in process improvements associated with investigation processes• Cross-training as a Quality Contact to close investigations from other investigators & to close other reports in multiple quality systems.

San Diego, Ca

Responsible for teaching monthly classes online and in classroom and developing curriculum for the Sociology department. In addition, serves as LMS administrator for Blackboard online teaching platform.• Taught over 50 classes in subjects related to Sociology (Cultural Pluralism, Principles of Sociology, Popular Culture) • Taught over 1000 students online, in classroom settings, and on Military Bases.• Averages 4.25/5 rating in student evaluations for class quality, support, and engagement.

La Jolla, Ca

Provided instructional support for the Academic Services Department and served as liaison for faculty for online curriculum development and accreditation.• 2012 Presidential Player’s Award winner at National University for employee of the year out of 2000 employees• Reviewed over 700 student and faculty research applications for the NU Institutional Review Board• Trained over 105 faculty members in 16 departments in online curriculum development• Modified and created over 200 courses and degree programs alongside other faculty members• Member of the Institutional Review Board• Member of the Academic Graduate committee overseeing curriculum development

San Diego, California, United States

• Confirming COVID 19 lab results• Conducting COVID 19 disease investigations• Identifying contacts and opening contact investigations to be completed by the Contact Tracer Team• Providing home isolation requirements and instructions; providing County temporary lodging referrals as needed• Maintaining up-to-date information about COVID 19 disease prevention, transmission and investigation processes by attending weekly virtual Q & A sessions with epidemiology subject matter experts• Maintaining up-to-date and accurate data entry in an electronic charting system.• Notifying supervisors and appropriate administrators of any high-profile or high-risk exposures, deaths, and/or outbreaks• Maintaining case confidentiality

San Diego, California, United States

Provided training to volunteer election workers for upcoming elections on behalf of the Registrar Of Voters• Part of team that trained over 7000 poll workers throughout San Diego County.• Presented curriculum consisting of customer service skills, updated voting procedures and election laws.• Prepared reports about class performance including competence of volunteers for working at the polls.

San Diego, Ca

Provide analysis, training, troubleshooting, and Tier 2 Technical Support to patients and medical providers for Continuous Glucose Monitoring system and supporting software resulting in overall customer satisfaction.• Serves as an escalation point for VIP Customers• Consistently exceeds expectations for adaptability, communication, efficiency, and technical expertise year after year• 33% faster average handle time on calls to serve more patients and medical providers• Serves as an author for job aides and training documents for new and current products• Mentors Tier 1 Technical Support Representatives

San Diego, Ca

Provided Tier 1 technical support for financial advisors and staff with proprietary software, Salesforce, digital certificates, and email hosting. In addition, assisted with training and onboarding new clients and office staff.• Served an average of 40 plus clients and internal staff daily via phone and email• 20% faster average handle time on calls to serve more advisors• Authored job aides and training documents for new and current products

Greater San Diego Area

Collected demographic, economic and housing data on behalf of the U.S. Census Bureau. Responsible for canvassing neighborhoods, documenting and reporting data • Completed over 500 interviews with residents and assisting with completing their census form.• Assisted people with completion of 2010 Census form and provided translation services in Laotian.

San Diego, Ca

Research Assistant IIProvided Support to Faculty by conducting experiments, gathering and analyzing information and data, and writing literature reviews and reports for sponsored research projects. Submitted research proposals for IRB approval.• Worked on 2 research projects focusing on youth offenders and second strike parolees.• Conducted and transcribed over 30 interviews and coded over 100 incident reports.

San Diego, Ca

Processed home equity loan documents for clients.• Closed and funded an average of 40 loans per month• Average loan closing time was 27 days.• Processed $1 million worth of loans per month

Ma, Sociology

Ba, Asian American Studies