Quality Assurance Technician

Viani Ram rez Irizarry

Tel: 787-***-**** **** Las Delicias

Email: ********@*****.*** Ponce, PR 00728-3827

Education:

Ponce School of Medicine - Ponce, Puerto Rico Graduation:

May, 2009

. Masters in Public Health, Epidemiology

University of Puerto Rico - Mayag ez Campus

Graduation: May, 2005

. Industrial Microbiology

Additional Education:

. Microbiological Method Validation Process Certification Course

February 9, 2008

. Laboratory Data Reviewer's Certification Course

July 7, 2007

Work Experience:

Packing Department, Roche Diagnostics, Ponce, PR March,

2009 - May, 2009

Packaging Technician

As a Packaging Technician my primary duties were to make sure that

the product was properly labeled, had all of its components, and that the

package was not damaged in the process. In case of a non-conformance,

inform the supervisor so that proper action could be taken. Also worked

programming the chip used with the product, and after finishing, the

required documentation was completed and the chips were sent to the

Packaging Department. At the end of each day, the production was documented

on an Excel table in order to report it at the end of the month's meeting.

Sartorius-Stedim Filters, Inc., Yauco, PR - Quality Assurance Department,

Validation Laboratory June, 2006-

March,2008

Validations Technician

As a Validations Technician I maintained communication with Sartorius

Corporation personnel to coordinate the validation projects. My primary

duty was to perform filter validation according to customer Protocol by

using Sartorius, Pall, and Millipore filters, customer product, and

bacteria. The validation started with testing the viability of the bacteria

in the customer product when mixed together. Depending on the viability

test results, a Bacterial Challenge Test was performed with the filters

selected by the customer. Bacterial identification tests, such as Gram

Stain and API 20E, were performed after the Bacterial Challenge Test was

finished in order to ensure the bacteria culture used was pure and there

was no contamination during testing. Chemical Compatibility Tests and

Product Specific Integrity Test (Diffusion) were also performed in order to

check the integrity of the filters. After the validation project was

finished and the results were documented, I performed the final review and

report of the laboratory batch records. In case of a non-conformance, an

investigation was performed and action was taken. I was also in charge of

the preparation of new bacteria culture, culture media and chemical

solutions, and the sterilization and decontamination of equipment and

products used. Other duties included: giving support to the microbiology

laboratory as required, suggest ideas to improve processes, preparation of

weekly schedule of laboratory tests, daily reading of temperature recorders

in ovens, incubators, and refrigerators, sterilization of laminar flow

hoods, environmental monitoring, and growth promotion and sterility tests.

The receipt, handling, inventory, and proper disposal of chemical products

was also my responsibility. Finally, I had the opportunity to write,

modify, and revise Standard Operating Procedures for the Validation

Laboratory.

Tyco Healthcare, Ponce, PR - Quality Assurance Department

Product Release Technician October, 2005-

June, 2006

As a Product Release Technician my primary duty was to review all

Device History Records from each batch produced in-house for accuracy and

completeness, and issue final release to market of all batches of finished

product using the SAP Program. Additional duties were the examination of

computer records concerning lots, instruments, and field returns to ensure

all transactions had been completed properly, and update and maintain

computer program (Access) to track and log all batches received in the

department.

Ponce School of Medicine, Ponce, PR

Research Technician Summer,

2005

Working with Dr. Anil Kumar, I was responsible of processing blood

from morphine-dependent and control macaques that were infected in an

SIV/SHIV nonhuman primate model of AIDS, by performing CBC test, isolation

of Peripheral Blood Mononuclear Cells (PBMC) with Ficoll and PBS,

Infectious Cell Assay (ICA), and Flow Cytometry and Analysis.

Centrifugation was performed in order to obtain the plasma from the blood,

and afterwards, RNA extraction from the plasma was performed, RT-PCR, PCR,

gel electrophoresis, and cloning. I also performed culture media

preparation and growth of healthy cells used in the experiment. These cells

were mixed with the infected monkey blood in order to observe the

cytopathic effect under the microscope.

University of Puerto Rico, Mayag ez Campus, Mayag ez, PR

Research in Microbiology Summer,

2004

Working with Dr. Rafael Montalvo, I was responsible for collecting

water samples from the solar salterns in Cabo Rojo, Puerto Rico in order to

study the molecular and morphological characteristics, and identify the

Archaea living in that environment. Filtration was performed using a filter

disk in order to separate the organisms from the water. The filter was

later placed in a culture media plate and incubated for growth. Afterwards,

the organism was purified and DNA extraction was performed followed by PCR

and gel electrophoresis. Gram Stain test was also performed in order to

ensure a better identification. Other duties included sterilization by

autoclave of laboratory equipment and culture media preparation.

Activities

. Vocal, SEMI ( Industrial Microbiology Student Society, in English)

. Softball

Awards

. 3rd Place: Poster Presentation, Public Health Category - 5th Annual

Scientific Meeting, Ponce School of Medicine.

Skills:

. Fully bilingual - Can speak and write fluently in both English and

Spanish.

. Comfortable working in teams or individually.

. Computer knowledge: Internet, Microsoft Word, Word Perfect, Excel,

Power Point, SAP Program, Access, EpiDat, and Minitab.

. Knowledge and experience working with GMP, GLP, and FDA regulations.

. Knowledge and experience with laboratory techniques such as: Aseptic

techniques, gel electrophoresis, colony purification, DNA and RNA

extraction, autoclave, Gram stain, culture media preparation, column

chromatography, dilutions, API 20E System, microscopy, membrane

filtration, pH determination, cloning, PCR, and RT-PCR.

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