Echo Lem Email & Phone Number

Pasadena, CA, US

City Of Industry, California, US

• QA Lab Manager
• Supervise total of 15 lab technicians at 3 laboratories for microbiology and chemistry. Validate testing method, review/create SOP, third party proficiency test, document control, and good laboratory practice.
• Investigate for trouble shooting out of specification test results and directs investigation process in manufacturing plant.
• Supervise sanitation monitoring program and environmental monitoring program include update and review working instruction.
• Validate and verify manufacturing process and equipment to ensure food safety and food quality.
• Inspect incoming raw material and implement quality inspection for new raw material.

• Study the growth, characteristics and effects of bacteria and other microorganisms to better understand their relation to human, plant and animal health.
• Perform API strips & troubleshoot issues and concerns regarding cross-contamination
• Adapt and understand the procedures from USP, FDA, EU, CTFA/PCPC, AOAC and others as needed.
• Responsible for troubleshooting out of specification test results and directs investigation process.
• Knowledge of current CTFA/PCPC, AOAC, USP, FDA, EU, ISO 17025 and other industry standard methods and procedures.
• Understanding of pharmaceutical, cosmetic and nutritional microbiology.

• Performance of microbiology test with USP Microbial limit testing and identification of organisms.
• Experience with microbiological tests of raw materials, in-process materials, finished products, dietary supplements, topical products, and OTC products.
• USP purified water system testing and reporting.
• Evaluate current methods- write, modify, and validate SOPs.
• Support and train all lab technicians and analysts in Microbiology Laboratory and Stability Department. (3 people)
• Proficient in BioLumix rapid testing system include calibration of equipment.

• Experience Laboratory Inventory Management System (LIMS).
• Maintains laboratory equipment and/or instrumentation, including scheduling of internal /external calibrations, routine maintenance, and resolve non-routine maintenance issues when they arise.
• Study growth, structure, development, and general characteristics of bacteria and other microorganisms.
• Isolate and make cultures of significant bacteria or other micro- organisms in prescribed or standard inhibitory media, controlling factors, such as moisture, aeration, temperature, and nutrition.
• Conduct and coordinate microbiological research in environment focused on innovations and product opportunities for food, industrial and personal care such as, drinking water and waste water testing, environmental.
• Develop strong research network and liaison with other company research centers, including developing and maintaining research relationships and projects with 3rd party partners and universities.

• Assertively performed and documented manufacture’s recommended Preventive Maintenance procedures on instruments.
• Operated various analyzing instruments.
• Performed, documented, and examined all P/M and QC data prior to release of any patient result.
• Maintained records and report all the problems to Lab Director or Technical Consultant as required.
• Identified, prepared, ordered, and maintained reagents and supplies as required.
• Juggled priorities to meet multiple demands of work assigned by Lab Director and Technical Consultant.

Clinical Laboratory Science, Clinical Laboratory Science/Medical Technology/Technologist

Bachelor Of Science, Microbiology Option; Clinical Laboratory Science