Senior Quality Control Analyst with 20+ Years Experience
Resume:
BICHHANG BUI
Vista, CA 92084 ***********@*******.*** Cell: 858-***-****
Senior Quality Control Analyst
PROFILE
Accomplished scientist specializing in microbiology with over 20 years of laboratory experience. Expertise in conducting microbiology and chemistry tests, ensuring product safety and regulatory compliance. Proven track record in streamlining quality control processes, enhancing operational efficiency, and developing comprehensive SOPs. Unique capability in implementing ISO standards and executing validation protocols, driving continuous improvement in laboratory operations.
EMPLOYMENT HISTORY
March 2008 Senior Quality Control Analyst, CAREFUSION/ BECTON DICKINSON, INC.
Conduct microbiology tests on medical devices, including Limulus Amoebocyte Lysate (LAL), environment monitoring, bioburden, and sterility dose audit. Execute inspection plans for product quality and ensure timely releases. Release products and generate monthly trending reports. Draft and edit SOPs, technical reports, and test procedures. Prepare documentation for ISO 9002 audits. Execute OQ/PQ validation on equipment.
. Conducted microbiology tests ensuring compliance with quality standards.
. Streamlined product release processes to enhance efficiency.
. Developed comprehensive SOPs improving operational consistency.
. Prepared through audit documentation supporting ISO 9002 compliance.
Jan. 2001- Dec. 2007 Quality Control Analyst, BOSTON SCIENTIFIC CORP.
Conduct microbiology tests on medical devices, including Limulus Amoebocyte Lysate (LAL), particulate, and sterilization validations. Oversee equipment validation processes, ensuring installation, operation, and process qualifications for Metler Toledo DL53 Titrator and other devices. Develop test methods and assays, executing special tests on MDSC, Melt Index, FTIR, and UV Vis. Maintain and calibrate laboratory equipment while drafting SOPs, and procedures.
. Conducted microbiology tests ensuring product safety.
. Validated equipment
. Wrote and edited SOPs, protocols, technical reports, and procedures.
. Organized laboratory to ensure operational efficiency.
Sep. 1999- Jan. 2001 Chemistry Analyst, BOSTON SCIENTIFIC CORP.
Conducted analysis and testing of incoming chemicals, resins, and solvents from vendors. Ensured compliance with FDA requirements prior to release. Executed chemical tests on Reverse Omosis water, Total Organic Carbon, Hydrite1000, viscosity, moisture content, and ETO sterilization.
Achieved 100% compliance with regulatory standards.
Streamlined testing processes, reducing analysis time by 15%.
Enhanced quality control measures, improving product reliability.
BICHHANG BUI 858-***-**** Page Two
Jun. 1998- Sep. 1999 Laboratory Research Associate, Microbiology, INFINITY II LABORATORIES INC.
Conducted microbiological testing for medical device industries, including bioburden and LAL tests. Implement ISO 9002 standards to enhance laboratory operations. Oversee quality control of stock organisms and media. Manage procurement of laboratory supplies.
Executed sterilization validations to ensure compliance.
Lead environmental monitoring initiatives to uphold safety standards.
Jun. 1997- Jun. 1998 Research Technician Internship SCRIPPS RESEARCH INSTITUTE
Executed cell culture tests, prepared media and chemical solutions, and maintained sterile techniques and glassware. Classified DNA gels performed GST-DNA, purification, plamid preparation, transformation, and ligation. Carried out microbiology tests on medical device life testing.
Developed and optimized protocols for DNA purification and plasmid preparation.
Maintained laboratory equipment toensure compliance with safety standards.
COMPUTER SKILLS
Excel
Microsoft Word
Outlook
WinKQCL
SAP
PowerPoint
SKILLS
Microbiology/ Chemistry Testing Expert SOP Development
Quality Assurance/ Quality Control Expert OQ/PQ Validations
ISO Standards
EDUCATION
BS, Biochemistry and Cell Biology – University of California, San Diego, CA
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