Quality Control Assurance
Resume:
DARIO HERNANDEZ
Roselle, NJ 07203-1638
***********@*****.***
OBJECTIVE:
To obtain a position as a Quality Assurance Clinician in a quality
department where I can use my past experience with FDA, ISO, and GMP
regulations to make professional decisions that influence my career
development and company objectives.
Summary of Qualifications:
Twenty years of experience in the performance and administration of
procedures within clinical laboratories. Specific areas of expertise
include:
Test Stages:
. Unit Test
Biological Test
Integration Test
System Test
Alpha Test
Regression Test
EXPERIENCES:
Ortho-Clinical Diagnostic, Inc. Raritan, NJ
Serologist/Scientist II Tester (1998-Present).
. Complaint Handling Unit, Performs analysis of customer complaint data
and identifies products quality trends to provide inter-department
feedback for investigation and resolve products quality issues.
Familiarity with FDA regulations and ISO9001 standards pertaining to
clinical chemistries, virology, and immunohematology assays. Testing and
acceptance of products, validation, and calibration and maintenance of
equipment according to standards and regulations. Ensuring that product
quality meets the most up-to date industry assurance. Responsible for
training new personal in my department.
. Working as a Biological and Software Tester on the Autovue application
for blood bank Instruments.
. Worked in the development of a fully automated blood analyzer with two
main components, the STU computer board and the image processing board.
Performed System testing and regression tests.
. Assisted and reviewed tests protocols and design history files related
to development of blood bank product/instrumentation.
. Suggested improvements in the adaptations to methods and processes
related to development blood bank products and instrumentation.
. Assisted in safety compliance and documentation activities in the
department.
. Responsible for the quality and accuracy of technical information
presented to management.
. Performed system testing including regression testing, Y2K testing and
integration tests.
. Analyzed and presented data used to accept or reject
products/instruments, including demonstration of equivalence to other
methods available.
. Performed system test cases and implemented system change requests
utilizing different Operating Systems during software validation.
. Responsible for activities supporting overall Quality review and
determination of disposition of in coming raw material.
. Provides assistance to quality representatives serving on projects
team with follow up and projects related to the team function.
. Staying on top of the FDA regulations, knowing the latest changes and
developments in the QA professional.
Modern Diagnostic Lab Inc.,
Clinical Lab Technician (1988-1997.
. Performed testing in all areas such as Hematology, Chemistry, Serology
and Urinalysis.
. Assisted in quality control and calibration of equipment and drawing
blood (phlebotomy). Instruments utilized included Paramax, Coulter
counting JR and Stratus.
New York Blood Center,
Clinical Lab Technician (1991-1997).
. Calibrated instruments, and pipettes. Performed parallel testing,
tracking quality control, accuracy and precision of the instruments.
. Performed (HIV), HBSAG, HCV, Core, and Sickle cells, P24, HTLV-1, ALT
and RPR. Instruments utilized included Abbott PPC, PPC, Olympus 600 and
Ortho Summit.
EDUCATION:
B.S., Science, Major: Anthropology/Biology/Chemistry
Lehman College, June 1998
A.S., Science, Minor: Biology/chemistry
Bronx Community College, June 1985
Training:
. Certificate in MS Access-2000
. Validation Training
. GMP/GLP Training
. FDA Readiness Training
Contact this candidate