Quality Assurance Manager

CALOGERO PALESI

*** ******** *** *******, *** YORK, 10705

914-***-**** e-mail: *********@*****.***

Summary of Qualifications:

Results-oriented, high-energy, hands-on professional, with a successful record of

accomplishments in the cellular therapy laboratory, training, blood banking and quality

assurance management. Experience in the blood banking industry, hematopoietic

progenitor cell processing from various cell sources, ultra-low temperature freezers

qualification, validation, and maintenance, quality assurance, training and customer

service with focus on providing the recipient with the highest quality cellular therapy

products. Quality Assurance management professional with ability to direct and improve

quality programs, reducing adverse events and improving overall efficiency and

productivity. Highly adept at developing and implementing test strategies, operational

procedures and quality methodologies to support the Cellular Therapy Transplant

Program. Fully compliant with FDA cGMP Code of Federal Regulations, AABB

accreditation, CAP accreditation and New York State laws.

Major strengths include strong leadership, excellent communication skills, competent,

strong team player, attention to detail, dutiful respect for compliance in all regulated

environments, as well as supervisory skills including hiring, termination, scheduling,

training, payroll, and other administrative tasks. Thorough knowledge of current

manufacturing practices, and a clear vision to accomplish the company goals. Computer

and internet literate.

Professional Accomplishments:

Manager of the Hematopoietic Progenitor Cell Laboratory and Quality Assurance

Manager

Managed all operations in the Hematopoietic Progenitor Cell Laboratory for the

Montefiore Medical Centers, a FDA regulated manufacturing environment, as

pertaining to cGMP CFR's, NY State, CAP and American Association of Blood

Bank (AABB) regulations, and assure compliance with organization quality

systems.

Wrote, developed and maintained a HPC Laboratory Standard Operating

Procedure manual to facilitate process control, standardization of methodology

and adherence to all applicable regulations.

Wrote, developed and maintained a Quality Program manual to ensure and

maintain the best quality care in transplant services.

Formulated Quality Assurance plans and measured and monitored actual results

against plans.

Introduced cross-training of blood bank technical staff to assist in freezers alarm

response during weekends and off-hours to improve quality level.

Educated and trained technical staff and residents in the processing,

cryopreservation and infusion of peripheral blood progenitor cells, bone marrows

and cord bloods.

In serviced technical and nursing staff on quality issues, and good manufacturing

practices.

Responsible for monitoring patients engraftment and adverse events following

transplant and reporting to the Medical Advisory Committee monthly meeting.

Established and validated a plan for monitoring and counting viable and non-

viable particle counts in the clean laboratory area.

Validated “Freezerworks Unlimited” a standalone computer database employed to

track freezer inventory, sample management and sample tracking.

Extensive experience handling a variety of different clientele through various

levels of communication, from independent agents, to medical faculty, to

independent contractors.

Processed, manipulated, and cryopreserved over 7,000 cellular therapy products

from bone marrows, to peripheral blood progenitor cells and therapeutic T-cells,

to cord bloods.

Performed CD34 enumeration, leukemia/lymphoma immunophenotyping,

immunomagnetic bead purging and CD34+ selection.

Performed routine hematological procedures and techniques including quality

control of cell counter and proficiency testing.

Performed all blood banking serological testing of patient samples.

Performed recovery and identification of Yeasts in beverages and syrups using

special techniques.

Work History:

Montefiore Medical Center, Bronx, NY: Hematopoietic Progenitor Cell

Laboratory Manager and Quality assurance Manager 2000 to present

Sound Shore Medical Center, New Rochelle, NY: Blood Bank Technologist per

Diem 1995 to present

New York Blood Center Clinical Services, Valhalla, NY: Clinical and Research

Technologist 1991 to 2000

PepsiCo, Valhalla, NY: Associate Microbiologist 1989 to 1991

Education:

Iona College, New Rochelle NY Bachelor of Science 1991

Westchester Community College, Valhalla NY Associate in Applied Science,

Medical Laboratory Technologist 1987

Northern Westchester Hospital School of Medical Technology, Valhalla NY

Medical Laboratory Technologist Certificate, 1990

Some graduate courses taken

Certification:

American Society of Clinical Pathologists, 1991

New York State Clinical Laboratory Technologist License

New York City Fire Dept Certificate of Fitness C-14 and G97

Abstracts/Publications:

HPC-A Collection Efficiency and Engraftment between HIV and Non-HIV Patients

with Lymphoma. Andrea Chakrapani, Carlo Palesi, Kala Mohandas, Joan Uehlinger,

Ljiljana Vasovic. Department of Pathology, Montefiore Medical Center, Albert Einstein

College of Medicine Bronx, NY, 10467.

Loss of Viability of Stored HPC-A and Peripheral Blood Samples by 7-AAD

ISHAGE Method. J. Pu, D. Broughel, J. G. Pizzolo, C. Palesi, H. Ratech, K.

Mohandas, L.V. Vasovic. Montefiore Medical Center, Albert Einstein College of

Medicine Bronx, NY, 10467.

Comparison of HPC Counts by Sysmex Methodology and Viable CD34+ Cell

Counts by Flow Cytometry in HPC-A Products. Danielle McClain, C. Palesi, K.

Mohandas, L.V. Vasovic.

Montefiore Medical Center, Albert Einstein College of Medicine Bronx, NY, 10467.

Transfusion Support in Hematopoietic Progenitor Cell Transplant Patients. Ljiljana

V. Vasovic, Kala Mohandas, Ronald Wash, Carlo Palesi, Pearl Bongolan, Joan

Uehlinger.

Montefiore Medical Center, Albert Einstein College of Medicine Bronx, NY, 10467.

References:

Furnished upon request

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