Henry Truong

Experience

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  Sicor-Teva Pharmaceuticals

  Aug 2003 - Oct 2006

  Chemist

  Prepared reagents, solvents, standards and sample solutions for HPLC testing.Operated general analytical instruments during testing (i.e., HPLC). Performed analysis on stability, intermediate and finished products (Assay, CU and Impurity). Troubleshot on analytical test and laboratory instruments (i.e., HPLC).Maintained appropriate documentation (records and lab notebooks) required by SOP’s.Performed Wet Chemistry tests (i.e., pH).Assisted in troubleshooting and problem solving. Worked directly with hazardous chemical substances in laboratory wet-bench setting. Ensured the safe receipt, movement, and use of hazardous chemical substances. Show less

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  Abbott Vascular

  Oct 2006 - Aug 2014

  Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. Performed risk analyses and FMEAs.Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.; Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development. Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.Provided Quality Engineering support to various cardiovascular medical device manufacturing lines in according with 21 CFR Part 80/810/820, ISO 9001/13485, and FDA regulations.Performed investigations, root cause analysis, and implement corrective & preventative actions for product nonconformances (NCMRs) found.Generate, review and approve Engineering protocols/reports, process validations (OQ & PQ), Impact & Risk Assessments, Quality test specifications, manufacturing process procedures, and equip qualification. Show less Laboratory Safety Action Team5 S – Continuous Process Improvement Value Stream Mapping – LEAN LABContract Laboratory PO/InvoicesMethod Transfers and Method Equivalency StudyLaboratory Compliance and Auditing.Process Improvement and Cost ReductionCertified as a CAPA Initiator/Evaluator – successfully initiating more than 10 OOS for non-conformance and recognizing OOS, OOT, and exception events. Initiates and conducts laboratory investigation.Experience in coordinating testing effort such as receiving incoming samples and assigned testing accordingly. Ensuring quick turn-around-time and meeting manufacturing schedules.Review and Approve cGMP notebooks, protocols, reports.Experience in develop over 6 protocols and reports for method transfer, method verification and method equivalency.Method development, validation, verification, and transfer by following established protocols whenever requiredExperience in Change Request (CR), Change Order (CO), and 30 Days Notice. Executing over 20 change requests and change ordersStrong communication and interaction with internal and external customersUnderstands and follows cGMP requirements with respect to laboratory operation, testing, results generation, and documentation. Show less

  • Quality Engineer

    Jun 2010 - Aug 2014

  • Chemist/Project Leader

    Oct 2006 - Jun 2010
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  Resichem Industry Ltd

  Aug 2016 - Jan 2018

  Director of Operation

  Oversee manufacturing, import and export, purchase and sale departmentsMonitoring revenue margins and worker productivity, as well as implementing new directives for growthEnsuring financial targets and other agreed targets are met in all departments. Driving the business to increase profitsInvestigating customer satisfaction and reporting any issues

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  Terumo Blood and Cell Technologies

  Jan 2018 - now

  • QC Laboratory Manager

    Apr 2022 - now

  • Project Engineer

    Jan 2018 - Apr 2022