QC Microbiology III/BioAnalytical - Minaris Regenerative Medicine (Advance Therapies) - Mountain View, CA
(2019-02 - 2025-08)
- Performed in-process product testing for glucose, lactate, and pH using blood gas analyzer.
- Test ed product for Endotoxin.
- Performed routine environmental monitoring (airborne viable, surface viable, and particulate) in ISO 5, 7, and 8.
- Performed in-process environmental monitoring for Manufacturing Cell Therapy.
- Performed sterility testing using BacT Alert.
- Performed bioburden testing using milliflex.
- Responsible for sending out lab equipment for calibration.
- Performed periodic review on laboratory equipment.
- Performed microbial enumeration.
- Initiated deviations and investigations pertaining to Environmental Monitoring out of spec results.
- Supported role to clinical and commercial production and provide environmental monitoring data to ensure that quality standards are upheld for all products produced at the facility.
- Trained on cGMPs, GLPs, and Aseptic Technique/Process.
- Performed documentation according to written Standard Operating Procedures in accordance to Current Manufacturing Practices and Good Documentation Practices.
- Supported development and manufacturing of cell therapy products.
- SupportedQA walk through and internal audit during clean room operation.
- Communicated with other department concerning deviation, action results, and out of spec laboratory results.
- Initiated deviation and investigation for non-conformance laboratory testing result such as Out of Specification and Out of Trend Results.
- Responsible for sending out bacterial isolates samples to contract testing laboratory.
- Supported client and internal audit.
- Maintained GxP compliance.
- Trained QC Microbiology Analyst.
- Reviewed laboratory test forms, lab equipnment such as freezer, incubators, refrigerator, and data base both in QC and Manufacturing Department.
- Use MODA to transfer data.
- Trend environmental monitoring results.
Site Specialist II (GMP/Research) - Gilead Sciences (under ThermoFisher Scientific) - Foster City, CA
(2018-03 - 2019-02)
- Supported Research Department by performing routine laboratory operations, such as collecting and washing glassware in fully automated equipment.
- Distributed clean glassware to all GMP Research Laboratory.
- Maintained laboratory on daily basis.
- Reviewed logbook to ensure that operator filled all the necessary information.
- Performed Preventive Maintenance in all equipment on weekly and monthly basis.
- Performed laboratory inventory on weekly basis.
QC Technician (Microbiology/Chemistry) - Pepsico - Hayward, CA
(2017-10 - 2017-12)
- Responsible for raw material inspection and performed tests for analytical analysis, such as pH, CO2, acidity, sugar level, sodium and to ensure that it meets specifications.
- Performed chemical inventory.
- Performed laboratory inventory.
- Performed tests for product and water for microbiological analysis using membrane filtration.
- Experience in aseptic technique and clean room manufacturing environment.
- Operated manufacturing equipment, such as filler.
- Operated and maintained laboratory equipment (water bath, pH meter, densitometer, microscope, incubator, CO2 analyzer).
- Maintained detailed records of performed tests and results daily.
- Performed routine and non-routine laboratory testing.
- Worked in clean room manufacturing environment.
Microbiologist - Allergan, Plc (Under ADECCO) - Campbell, CA
(2016-03 - 2017-10)
- Supported CDC, FDA, CAPA and internal audit to ensure that all tests forms, log book, and database have completed information and no back dating.
- Reviewed batch record.
- Performed Microbial Enumeration on bacterial isolate.
- Received and inspected labels, lot number, and description of raw material and also to ensure that it meets specifications.
- Expertise in handling of bacterial cells, such as infectious microorganism (Clostridium botulinum).
- Experience in aseptic gowning technique, pipette use, and environmental monitoring.
- Collected samples on WFI, Clean Steam and tested for bioburden, conductivity, LAL, and TOC.
- Sent out samples to contract laboratory.
- Performed media growth promotion.
- Performed investigation on alert, action, and out of spec test result.
- Supported maintenance and calibration of analytical instruments.
- Responsible for planning and execution of testing schedule which contributes to the completion of milestone associated with specific projects.
- Maintained appropriate documentation (records, data sheet, lab note books) as required by SOPs.
- Complied with all cGMP, current Good Laboratory Practices and safety requirements, laboratory SOPs, and company policies and procedures.
