Dena Moncada Email & Phone Number

San Diego, California, United States

San Diego, California, United States

• Assisted management in method validation for implementing a new bioburden test system, Milliflex Oasis.
• Performed TAT broth comparability study to supplement current sterility testing procedure, utilizing laboratory notebook.
• Active member of the Environmental Health and Safety Committee, serving as department representative.
• Further developed data analysis skills, compiling and graphing raw data for trend reports.
• Developed technical writing skills by acquiring further responsibility in quality event writing.
• Developed skills as an SME in routine laboratory testing and responsibilities of previous titles, training new analysts as necessary.

Greater San Diego Area

• Operated SKAN isolator for use in sterility testing of final product.
• Identified bacteria and fungi obtained from environmental samples operating bioMérieux VITEK MS automated system.
• Performed bacterial endotoxin/LAL testing on raw product materials and utility samples using EndoScan-V Software.
• Paired lysate and endotoxin reagents for use in endotoxin testing, Kinetic and Chromogenic Technique, per Certificate of Analysis.
• Performed Endotoxin Gel-Clot analysis of final product.
• Utilized Milliflex membrane filtration system for bioburden testing of raw product materials and utility samples.

Greater San Diego Area

• Conducted routine environmental monitoring of grade A/B cleanrooms during injectable filling operations.
• Conducted routine environmental monitoring of grade C/D cleanroom manufacturing areas.
• Aseptically collected WFI and RODI water samples from various sites for conductivity, TOC, membrane filtration, and LAL testing.
• Sampled clean compressed air (CCA) for total water and oil content, air viable microorganisms, and total particulates.
• Sampled nitrogen gas (N 2 ) for aerobic/anaerobic microorganisms and total particulates.
• Performed general laboratory experimentation in compliance with SOPs and assisted in data interpretation.

Greater San Diego Area

Greater San Diego Area

Bachelor’S Degree, Biology- Microbiology Concentration; Minor In Chemistry

Associate’S Degree (As), Math & Science

Associate’S Degree (Aa), Social & Behavioral Science