Alejandro Ibarra

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.

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.

Bachelor of Science - Botany - Far Eastern University