UNIVERSITY OF PUERTO RICO, MEDICAL SCIENCES
Graduated in May 1992
SCIENTIFIC R. Nieves, J. Rodríguez and B. Bolaños 1991.
IPR PHARMACEUTICALS, INC., CANOVANAS PLANT, CAROLINA, PUERTO RICO
QA Advisor / Siete Development
Responsibilities included:
Review and approve all documentation generated for the new site on the assigned projects, computer validation, IQ’s, OQ’s, SOP’s, ER/ES compliance and cleaning validation. Provide QA consultancy. Participate in the installation, and operation qualification activities to prevent quality issues on the initial stages of the process. Participate in the investigation and consultancy of all the quality issues associated with the start up of the new site. Identify GMP deficiencies in the in the new facilities. Participate in the preparation for internal or external audits conducted in the new site (ICG, FDA, MCA, etc.). Develop the required quality systems to guarantee compliance throughout the process flow of the new site. Support the QA Site operations (laboratory and Documentation areas) for a smooth integration with the new site, by providing on time guidance of the process to be changed and the corresponding training.
Feb 2001 - at present
Advisor: Marcos Rodríguez
Microbiologist
Responsibilities included: evaluation of a new automate technology, start up of new laboratory facilities, budget management, purchasing, water testing using sterile filtration techniques, Environmental
samples tests, testing of Raw Material, instruments maintenance, culture media preparation, Control stock preparation, preparation of Standard Operation Procedure (SOP), preparation of Installation, Operation and Performance Qualification of new equipments, the develop of validation protocols for system and equipment, the develop of the analytical investigation to resolve different situation during the manufacturing process, and instruments maintenance.
May 1994 - Feb 2001
Advisor: Vilma Rodríguez
Medical Technologist
CENTRAL LABORATORY, C.D.T. DR. JAVIER J. ANTON,
RIO PIEDRAS, AND CENTRAL LABORATORY OF THE ADMINISTRATION OF MEDICAL CENTRO MEDICO, RIO PIEDRAS, PUERTO RICO
Highly specialized work that include areas like Hematology, Serology, Blood Banking, Biochemistry, Microbiology, Parasitology, and Urinalysis. Responsibilities included: management of routine specimens in regard to particular instrument on which they are run, reconstitution of controls and reagent, daily instrument maintenance, procedures performance in accordance to quality control levels; collection of blood specimen utilizing fingerstrick and venipuncture techniques, and also bleeding time procedures. Working as practician in a full-time basic as requirement to obtain the Medical Technologist Diploma.
Research assistant
MICROBIOLOGY AND ZOOLOGY DEPARTMENT, MEDICAL SCIENCES CAMPUS, UNIVERSITY OF PUERTO RICO, RIO PIEDRAS, PUERTO RICO
Responsibilities included: In charge of training and evaluation of the students staff, yeast culture media preparation, inoculation of fungus specimen, air sampling for the recovery of environmental fungus. Identification of the environmental fungus, chromatographic separation of Cryptococcus neoformans proteins, dilutional procedures, quantification of proteins, carbohydrates and polysaccharides. Phagocytosis procedure, extraction of rats alveolar Polymorphonuclear cells, separation of the humans polymorphonuclear cells, separation of proteins by Isoelectric Focusing System(Rotofor - BIO-RAD), dilution preparation of antifungal drugs, cells strain, and a chemotaxis Response Assay. Working in a part-time basis while attending college.
December 1990 - May 1992
Advisor: Dr. Benjamín Bolaños
BIOLOGY DEPARTMENT, UNIVERSITY OF PUERTO RICO, RIO PIEDRAS CAMPUS, RIO PIEDRAS, PUERTO RICO
Responsibilities included: Daily instruments maintenance, culture media preparation, inoculation of specimen, sampling procedure, Phagocytosis and Chromatographic procedure. Working in a part-time basis while attending college.
August 1990 - December 1990
Advisor: Dr. G. Toranzo