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.• Performed system suitability of Sievers 900/M9 autosampler for use in TOC analysis of utility samples.• Prepared received media and conducted growth promotion quality testing (GPQ) implementing proper aseptic techniques.• Tested reliability of autoclave and sanitization operations utilizing biological indicators.• Prepared biological and utility samples for shipment to contract laboratories for testing.• Prepared analyst qualifications for training purposes.• Launched quality events by writing and submitting deviations and issues via Master Control.• Proficient in writing investigation and deviation reports.• Utilized MODA-EM for data analysis• Organized and prepared historical data for trending, archiving and storage.• Reviewed logbooks, data, and issued analyst corrections.• Maintained status of lowest number of data entry and paperwork corrections in department.

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.• Prepared samples, collected data, and entered results utilizing MODA-FDC application.• Prepared paperwork and maintained documentation of results from experiments performed including appropriate calculations.• Received samples for testing and documented results on corresponding batch records.

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