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.• Validate new sanitation chemical, vendor, CIP, and COP process.• Perform internal audit ISO 9001 201, BRC, and gluten free program per requirements.• Monitor state release product, USDA product, and Kosher product and work closely with inspector.• Provide Allergen Program, cGMP, GLP, Chemical Safety, Sanitation, Norovirus awareness, and Cross Contaminant Prevention training and training material to all employee.• Work closely with Research & Development and Production function for new product and process validation.• Familiar with FDA Code of Federal Regulations [CFR 21 Part 111], acidified food requirement, BRC, HACCP, FSMA, ISO 17025, and ISO 9001 2015.CERTIFICATES• BRC certification issue 8 (2023)• Seafood HACCP (AFDO 2023)• Gemba Safety (2023)• Good Manufacturing Practices for Food Industry (CDPH,2018)• Environmental Monitoring Program (Eurofins, 2018)• Food Defense (FDA, 2019)• Acidified Food Processing (Chapman University,2017)• ISO Internal Auditor Training (SGS, 2017)• ISO 9001:2015 Requirement for Quality Management Systems Training (SGS, 2017)• FSPCA Preventive Controls for Human Food (IFPTI, 2017)• Harassment Prevention for Supervisors CA (CalChamber 2017)• Excelling as a Manager or Supervisor (SkillPath,2016)• HACCP (AIB,2016)

• • 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.• Understanding and knowledge of the European, United States, Japanese and other Pharmacopeias.• Experience performing microbial testing on pharmaceutical, cosmetic and nutritional raw materials, water samples, bulk & finished products, ISO 17025 and Cclients’ proficiency tests, Preservative Effectiveness Testing USP <51> and PCPC/CTFA, Kill Time Study, Antibiotic Microbial Assay USP <81>, Suitability Test and Growth Promotion USP <61>, etc.• Able to handle multiple tasks and work in a fast paced environment.• Able to adapt to changes to improve company process.• Oversee and supervise work performed by Senior, Microbiologist and Microbiology Technician (6-7 people).• Communicate job expectations and manage employee performance.• Help subordinates address and resolve concerns and complaints.• Assist executive management to implement company procedures and policies.

• 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.• Ensure compliance with FDA, NPA, cGMP guidelines for maintenance of equipment and personnel training records and successful track record on audits.

• 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 hygiene include surface, personal and hand hygiene, allergen swabbing and allergen testing, and challenge testing assist with evidence for establishment of shelf life.• 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.• Perform project tasks and research activities within laboratory, and manage projects and teams to ensure target deliverables are achieved.• Support and train all lab technicians and analysts. (2 people)• Experience with ISO guidelines with preparing/reviewing and approving work procedures and SOPs.• Ensure compliance with ISO guidelines for maintenance of equipment and personnel training records. • Successful track record on FDA & ISO audits and proficiency testing.• Capacity to design, perform and analyze results of shelf life tests, challenge studies and antimicrobial effectiveness assays.• Enhance research capabilities both internally and externally to optimize introductions of written reports, intellectual property and patents, delivery of project targets, and new innovations to marketplace.

• 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.• Perform phlebotomy with adults, pediatrics, and neonatal.

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

Bachelor Of Science, Microbiology Option; Clinical Laboratory Science