QC final inspections
Resume:
Vivian Nguyen
*****************@*****.***
San Jose, CA 95111
linkedin.com/in/vivian-nguyen-85b65018
Self-motivated and team player QC Technician Lead having inspection and testing experience, production over16 years. Troubleshooter/QC Analyst in an FDA/ GMP and fast pace medical device manufacturing environment seeking new opportunity to learn and to contribute to success of the organization.
SUMMARY :
Failure investigation and root cause analysis, finish production testing, functional Testing in process Monitoring and Troubleshooting. Reliable and strong interpersonal skills, GMP and FDA regulated clean room practices. Use of Pipette and biohazard us lab containment practices, Visual inspection under magnifying lamp and microscope of small and detailed quality attributes. Attention to details and numbers: Review of batch record for accuracy and GMP compliance and Line Clearance. Blood Born Pathogen Training and 5S. Computer skill, data entry, Microsoft Excel and Outlook.
PROFESSIONAL EXPRIENCE:
Cepheid Company. Newark, CA 2021-Present
QC Analyst:
Coordinate schedule of QC Analyst and support the production and engineer group
Perform and document laboratory testing of finished product per procedure.
Work in Class B & C labs
Conduct data analysis according to established methods and product specifications
Review DHR and upload to Camstar .
Assist with nonconformance investigates
Zoetis Inc (Formerly Abaxis Inc) 2020-2021
QC Analyst:
Perform all duties of Rotor Production Troubleshooter across 3 semi-automated production lines
Review finished batch records for accuracy, GDP error and Final Lot Release disposition
Abaxis Inc / Zoetis. Union City, CA 2014 -2020
QC Technician Lead:
Coordinate schedule of 11 QC Technicians to support 3 production lines on 1st shift
Perform all testing and inspection duties of QC Technician 2
Abaxis Inc. Union City, CA 2010 to 2014
QC Technician2:
Perform in-process functional testing of rotors (consumable medical devices) in Vets can analyzers with biohazardous blood sample according to procedure in rotor QC lab
Process and save data using computer and custom software
Analyze chemistry testing results against released limits, record findings and report issues to Troubleshooter
Perform QC Final Inspection and QC Final Packaging Inspection of critical to quality attributes, record findings in batch records according to procedures, and alert Troubleshooter about failures and defects found
Verify line clearance performed by Production group and document findings in batch records according to SOP
Abaxis Inc. Union City, CA 2007 to 2010
QC Technician 1:
Perform QC Final Inspection of critical to quality attributes, record findings in batch records according to procedures, and report failures or defects to Troubleshooter
Perform QC Final Packaging Inspection at the end of the production, record findings in batch records according to procedures, and report failures or defects to Troubleshooter
Perform machine start-up verification, and record findings in batch records according to procedures
Abaxis Inc. Union City, CA 2003 to2006
Assembler 1:
Load and unload rotors in automated manufacturing equipment per released SOPs
Visually inspect rotors for bead defect under magnifying lamp and record findings according to procedure under a fast-paced environment
Perform inspection under microscope for weld defect and record findings according to procedure under a fast-paced environment
EDUCATION
License Financial Specialist 2021-Present
High School Diploma in Phu Nhuan High School, Saigon Vietnam
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