EXPERIENCE

**/ **** – Current Business Analysts II (07/2010 – Current)

Responsible for development, support, integration, writing and execution of test scripts of LIMS Labware which included the Environmental and Stability module for Pharmaceutical Industry.

Configuration of Product specification table in change control system.

System administrator for the NuGenesis (SDMS) system.

1998 to July 2010 TEVA PARENTERAL MEDICINES – Irvine, Ca

Microbiologist I (9/1998 – 2/2000)

Microbiologist II (2/2000 – 2/2007)

Sr. Supervisor (2/2007 – 07/2010)

Business Analysts II (07/2010 – Current)

Responsible for development, support, integration, writing and execution of test scripts of LIMS Labware which included the Environmental and Stability module for Pharmaceutical Industry.

Manage and supervise 16 lab technicians and 2 Microbiologists.

Various Microbiological testing per USP methods.

Performed method validation for microbiological qualification testing.

Develop testing process, materials and equipment for increase efficiency.

Review of Microbiologial data for finished product and stability testing.

Review of environmental monitoring data for aseptic process environment.

SOP review and update.

Creation and completion of investigation using Trackwise.

Data compilation, review, and evaluation.

Involve in global quality remediation process.

Develop and implementation of LIMS (labware) following strict guidelines.

Responsible for the development and maintenance of the LIMS application including configuration, design and development programming, as well as design and execution of validation and test protocols.

1995-1998 Chiron Visions / Bausch and Lomb Pharmaceutical - Irvine, CA

Laboratory Technician (8/1995 to 8/1996)

Associate Microbiologist (8/1996 to 9/1998)

Responsible for all aspects of Microbiology testing which included Bioburen, LAL, Sterility testing.

Review sterilization batch record, writing and execute protocols.

Steam sterilization of finished products.

Conduct aseptic fill validations, Monitored cleanrooms, BI testing and all related functions.

Bioburden testing of water sample and in-process materials.

Endotoxin testing of water samples, and of finished product samples using gel-clot method.

Write and execute protocol for gamma dose audit sterilization validation, and temperature mapping and D-value evaluation for steam sterilization using Kay Digistrip.

Review of sterilization batch record for gravity steam, ethylene oxide, and gamma sterilization.

Preparation and seeding (BI) of the simulated validation load (labor intensive) for steam and

ethylene oxide sterilization.

Sterility testing of finished product and biological indicator by direct immersion.

Conducted aseptic fill validation (manual filling) for corneal storage media.

Monitoring of ISO Class 5 active / dynamic and ISO class 7.

1994 to 1995 Ansys Incorporated Irvine, CA

Laboratoy Technician

Responsible for laboratory testing of physical and chemical testing of WIP of raw materials.

Variety testing of physical and chemical testing on raw material and finished product under minimal supervision e.g. Paper chromatography, visual inspection for contaminants.

Weekly audit of controlled substance.

Disposal and labeling of hazardous waste.

General organization in the laboratory

Daily and weekly calibration of micro calipers.

EDUCATION B.S., Medical Technology, Trinity College of Quezon City, Philippines

PROFESSIONAL LIMS LABWARE Administration 1 and 2

ORGANIZATIONS/ Advance Configuration Using LIMS Basic

CERTIFICATIONS

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