Performing and monitoring critical manufacturing related processes.
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]) per SOP.
Preform trouble shooting when necessary.
Collaborate as part of a cross-functional team (i.e., QA/QC, F&E, NPI in completing production activities.
Identify and raise concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions.
Entry of samples into LIMS
Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area.
Clinical Lab Technician
Esoterix
Calabasas, CA
04.2024 - 10.2024
Prepared & tested specimens under established SOPs with the technical oversight of a Clinical Lab Scientist.
Performed pipetting using pre-set, calibrated and automatic devices or fixed volume dispensers.
Performed preventative maintenance and troubleshooting of automated equipment.
Monitored data entry & accessioned patient sampled into the LIMS.
Microbiology QC Analyst
Instilbio
Tarzana, CA
05.2022 - 03.2023
Performed Environmental Monitoring testing including EMPQ and routine testing in a cleanroom in compliance with US and international (e.g. FDA, ISO, EU, ICH, GXP) regulations.
Entered and verified Environmental trending data.
Executed internal product testing including growth promotion, bioburden, rapid sterility and endotoxin.
Supported external microbial ID send out, EM trending, and deviation investigations.
Interfaced with cross-functional groups such as manufacturing, facilities, supply quality, QA.
Updated and reviewed SOPs.
Lead Microbiologist Technician
CC Testing Labs
Northridge, CA
07.2021 - 04.2022
Carried out internal quality control assessments for microbiology.
Preformed DNA extraction and qPRC followed by interpretation of results & data entry.
Prepared media and reagents used for testing.
Trained microbial technicians in aseptic methods, SOPs, and complying with legal regulations (Cal-OSHA, DCC).
Prepared process quality control organisms.
Data management and verification of data produced.
Education
Bachelor of Science - B.S. Medical Technology/Biotechnology