Luong Nguyen

Normal person, I'm working for Medical Devices company

BDC Laboratories Test System: (Hydrodynamic BDC-HDTI-6000. Pressure Monitoring System) BDC-VDT- 3600i (Slop and Offset valves using measurements, the transducer Calibration process.

Duties: Perform receipt and disposition of incoming apheresis material. Perform verification/inspection and ensure timely issuance of production documents and labels. Perform shipment authorization. Perform incoming label inspection. Review batch-related documentation and ensure resolution of issues to release and ship product. Ensure timely resolution and escalation of issues in operation. Ensure all product-related Deviations are initiated, investigated, and resolved. Vendor management Ensure that associated CAPAs are initiated and resolved, as needed. Ensure approval and timely delivery of final product. Ensure products are manufactured in compliance with regulatory and GMP guidelines. Ensure products are manufactured in compliance with regulatory and GMP guidelines.

Quality

Assurance supports resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues. Gather metric information for use in continuous improvement of areas of responsibility. Maintain/Update huddle board tracker, deviation tracking log, task tracker and issue monthly reports. Maintain database of relevant Quality documents to include but not limited to: Supplier Approval documentation, Laboratory Logs, Certificates of Analysis, Sanitation Logs, and Temperature Logs. Accurately interpret lab results, create graphs, and trend data as required.

Conduct Facility

Self-Audits and assist in employee training of FSQA Programs.

• Responsible for ordering products, services, and raw materials for the company or organization. Conducting product research and sourcing new suppliers and vendors.
• Sourcing materials, goods, products, and services and negotiating the best or most cost-effective contracts and deals. Performing inventory inspections and reordering supplies and stock as necessary. Conducting market research to keep abreast of emerging trends and business opportunities. Inspecting stock and reporting any faulty items or inconsistencies immediately
• Verifies purchase requisitions by comparing items requested to the master list and recommends alternatives. Provides purchasing planning and control information by collecting, analyzing, and summarizing data and trends. 
• Forwards available inventory items by verifying stock and delivering schedules. Prepares purchase orders by verifying specifications and price, while obtaining recommendations from suppliers. Secures approval from requisitioning department.
• Manages purchases by forwarding orders to suppliers and monitoring and expediting orders. Verifies receipt of items by comparing items received to items ordered; resolves shipment errors with suppliers.
• Troubleshooting and resolving technical problems in receiving inspection. Provide documentation support and complete written reports on inspections, designs, and component qualification activities. Actively participate in component drawing reviews and provide relevant feedback for teammates. Perform verification of material temperature data and temperature requirements to ensure conformity to data records and time of receipt. 
• Assist in assembling data package of qualification testing for submittal.
  • Assist and/or participate in drawing reviews.
  • Assist or conduct customer source inspection when required.
  • Assist manufacturing and production in resolving quality related problems.
  • Ensure proper control of internal documents.

: Bachelor of Science: Accountant/Business Management - California Southern Attitude of Technology