Bùi Hoàng Thanh Long

Utilized advanced techniques (MLPA, FISH, Karyotype, Sanger/Next Generation Sequencing, Real-time PCR) for comprehensive genetic analysis in various areas including prenatal testing, mental retardation diagnosis, and infectious disease (COVID-19) detection. Analyzed biometric and ultrasonic data using Excel and R to establish diagnostic models. Performed venipuncture for blood sample collection. Cultivated and analyzed human chromosomes from amniocentesis and blood specimens. Interpreted combined results from various tests to reach accurate diagnoses of genetic abnormalities. Maintained laboratory quality assurance through proficiency testing and equipment troubleshooting/repair. Documented test results and insights into laboratory information systems (LIMS, HIS). Prepared performance reports to monitor laboratory efficiency.

Generated insightful sales reports (monthly & weekly) to facilitate real-time performance analysis. Collaborated with a team to ensure accurate recordkeeping and timely file updates. Maintained strong client/department relationships, keeping stakeholders informed of financial developments. Leveraged material master data and BOMs (Bills of Materials) to forecast demand for new products. Developed material, manufacturing, and purchasing plans for related departments.

Led the QC department in adhering to strict quality standards (GMP, GLP) and company policies. Optimized workflow by efficiently scheduling and distributing work to ensure timely completion and release of products (raw materials, in-process, finished). Championed a culture of quality by ensuring staff competency through training on SOPs for environmental monitoring (water sampling, settle plates, RODAC, air plates). Proactively identified and resolved potential issues impacting compliance, product quality, and availability, ensuring appropriate product release/rejection decisions. Collaborated with management to streamline operations and improve departmental efficiency. Investigated Out-of-Specification (OOS) results, documented them thoroughly, and provided technical support to Manufacturing, Quality Assurance, and R&D. Provided regular progress reports to management on product testing status and completion timelines. Collaborated with colleagues to develop and implement laboratory documents (SOPs, Specifications, Protocols, and Reports) while training analysts and conducting OOS investigations. Managed Material Requirements Planning (MRP) for the Microbiology Team, ensuring proper material availability for QC activities.

Led the development, review, and execution of validation protocols for equipment, processes, cleaning, and analytical methods, ensuring compliance with regulatory requirements (GMP, GSP) throughout the process. Provided technical expertise in validating new and existing processes, equipment, and systems, including risk assessment and comprehensive documentation. Collaborated cross-functionally with Quality Control, Manufacturing, and R&D to establish validation strategies and timelines. Managed validation documentation (plans, protocols, reports, deviations) for completeness and accuracy. Conducted risk assessments to identify critical parameters and potential validation issues, proposing mitigation strategies. Supported internal/external audits and regulatory inspections by providing validation documentation and expertise. Investigated validation discrepancies, deviations, and Out-of-Specification (OOS) results, implementing corrective and preventive actions (CAPAs). Delivered training on validation principles and procedures to ensure company-wide understanding.

Developed and implemented a comprehensive hospital quality indicator system aligned with national health ministry guidelines and international standards from AHRQ, ACHS, and WHO. Leveraged data analytics and interactive dashboards to identify trends, performance patterns, and improvement opportunities in healthcare delivery. Collaborated cross-departmentally to conduct regular self-audits and assessments of healthcare processes, services, and facilities, ensuring quality improvement and patient safety. Investigated patient care incidents, complaints, and non-conformities, conducting root cause analysis (RCA) and implementing corrective and preventive actions (CAPA) to prevent recurrence. Championed the implementation of the ACHS International EquIP-7 Quality Assessment and Improvement Program, including translation of materials, document compilation, and program monitoring. Contributed to quality improvement initiatives through participation in research projects, project development, and the creation of Standard Operating Procedures (SOPs).