Quality Control Manager

Bharat D Naik, CLS (NYSED).CMTO.CSMLS, PhD.

**** ***** ****. *****. ** 75074

(972)***-*************@*****.***

OBJECTIVES

• Experienced medical technologist with NYSED/CMLTO/CSMLS certification, over 15 years of experience

as a Clinical lab technologist and 5 years as Supervisor/Manager with doctorate, master and a bachelor's degree in

medical Science/ Life Science. Searching for a Management position in the progressive hospital lab.

• Εxcellent clinical laboratory skills, with commended performance conducting/analyzing laboratory assays

and resolving complex clinical and instrument problems.

• Accurate, reliable, diligent and focused on the timely, quality completion of all lab procedures. Work well

under pressure and time constraints within high-volume environments. Profound experience of leading and managing

clinical laboratory activities and functions.

WORKEXPERIENCEMedical Technologist

Dec.2011 to Present: Operational Manager, Med Fusion Clinical Lab, Lewisville.TX

Sept.2008 to November.2011. Supervisor, STAT Lab. Kaleida Health, Gates Circle Hospital. Buffalo. NY

Aug.2006 to Sept.2008 Technical Recourse Specialists. Core Lab. Massachusetts General Hospital, Sr. Cell

Therapy Specialist, Dana Farber Cancer Institute.Boston.MA

• Responsible to lead the laboratory operational facility and be in-charge of its activity.

• Directed Clinical Laboratory operations and responsible for the analytical results produced by the central

laboratory facility.

• Managed ongoing education of the central laboratory staff.

• Reported Management Team about Clinical Laboratory activities.

• Ensured safety regulations and local and global quality systems in the Laboratory, and followed all local

security procedures.

• Established and maintained the standard Laboratory Operating Procedures(SOPS)

• Advised Sales group on testing methodologies and analytical platform.

2004 To July2006 MTII Cambridge Hospital./ CHB. Boston. MA

1999 To 2004Sr. MT, MDS Internal Reference Lab. Toronto, Ontario. Canada

1990 To 1998 MT.CML Laboratory. Mississauga, Ontario. Canada

• Collect and prepare specimens and perform laboratory procedures used in the diagnosis, treatment and

prevention of disease. Verify record and report lab results on all performed tests. Ensure compliance with

government requirements, hospital policies and laboratory procedures, including maintaining the cleanliness

of lab equipment, instruments and work area.

Key Contributions:

• Executed and analyzed tests in areas including chemistry, hematology/ Immunohaematology (Blood Bank),

urinalysis, serology, histology, and bacteriology to aid physicians in diagnosing and treating disease.

• consistently commended for the timely, high-quality completion of both routine and special laboratory assays

of patient specimens (including blood and other body fluids, skin scrapings and surgical specimens).

• Ensured test-result validity before recording/reporting results, earning a reputation for meticulous attention to

detail.

• Demonstrated the ability to communicate test results effectively with physicians, pathologists and nursing

staff as a member of interdisciplinary team focused on providing exemplary quality of care.

• Εvaluated quality control within laboratory using standard laboratory test and measurement controls, and

maintained compliance with CLIA, OSHA, safety and risk-management guidelines.

Bharat D Naik. 972-***-**** …Page2…

Technical expertise includes :

Medical Microbiology:

Isolation and identification of micro organisms from various body fluids. (Planting of specimens on culture media

using manual and automated (BacTek) techniques, incubating (aerobic and anaerobic), culture plate reading (colony

morphology/ Read 1,2,3 &4),Slide preparation, staining and reading of slides for bacterial morphology –Gram stain,

biochemical identification of bacteria using biochemical tests (API, QStr, QHae etc) and agglutinating polyvalent sera

– serotyping) ; Org. ID & Antimicrobial susceptibility testing –VITEK 2, Micro Scan Walk away; and reporting the

final results. Infection Control Practitioner - Expedited VRE, MRSA. Molecular Microbiology: Molecular

Microbiology diagnostic assays using DNA Probes “Gen-Probe AMP-CT and Tecan Genesis 150/8 System”.

Urinalysis: Microscopy and Chemistry. (CLINITEK500/Atlas-UF 1000i)

Clinical Chemistry: Estimation of hormones and metabolites from various body fluids using manual and automated

instruments. On hands experience in Special Chemistry, TDM, Toxicology and Immunoassays ( ORTHO ELISA);

Maintenance, calibration and trouble shooting on : TDX, IMX, Axsym, ARCHITEC 2000, LX 20, Cobas Integra 800,

Centaur (Roche), Hitachi 917, Immulite, Advia 1800,VARIAN HPLC, Saturn 2000 GC/MS, and AA 600 .

Haematology and Immunohaematology: Routine and Special techniques in hematology; CBC,MCH/, MCHC,

Retic, ESR, PT, APTT, Fibrinogen, Sickle Cell, Mono Abs, ANA, Differential WBC. Maintenance, calibration and

trouble shooting on GEN S, Thrombolyzer, Bayer Ad via System XE2100, HMX, Epik XP., STAGO etc. ABO/ Rh

Blood Grouping, cross matching and Ag/Abs screening, AB Elution.

Clinical Cell Therapy (Cell Manipulation) : PCA - stem cell - cellular product cryopreservation, cell enrichment

and purging, cell evaluation and sorting, cell culture, cell product thaw/wash and infusion. Calculations including,

viabilities, dilutions and cell concentrations. Aseptic handling of products at all times to ensure the integrity, viability

and sterility of cellular products until final infusion to the patient. Performs procedures and maintains accurate

documentation in compliance with the FDA's practices and regulations as well as standards set by other accreditation

agencies.

Cytogenetic: Broad knowledge of cytogenetic protocols in the processing, harvesting and staining of peripheral

blood, amniotic fluid, chorionic villus and tissue samples. Familiarity with hematological cytogenetic. Experience in

FISH protocols and analysis. FISH experience includes both metaphase and interphase analyses. Project: “Philadelphia

Chromosome – chromosomal abnormalities in patients with hematological disorders, study on Philadelphia

chromosome.”

Quality Control: Co-ordinate with QC/QA, maintained adequate records of any action required to be taken, also

maintained the precision and accuracy of methods employed through appropriate QC procedures., QAP, QCP quality

control knowledge, perform and final results submitted for LPTP(BIORAD), CAP regulatory agency.

Proficient with the Inter laboratory information System (LIS), MIDITEK, MYSIS, Cerner Millennium. Sun Quest

ATLAS.

Proficient in Microsoft Office Work. (MS Word, Excel, Power point)

EDUCATION :( Equivalency evaluated by World Education Services, NY.USA)

1990 PhD (Medical Science). Gujarat University. Ahmadabad. Gujarat. India.

1981 M.Sc (Medical Science / Life Science). Gujarat University. Ahmadabad. Gujarat. India.

1976 B.Sc (Microbiology/ Chemistry). Gujarat University. Ahmadabad. Gujarat. India

Certifications:

2009 Registered Clinical Laboratory Technologist. NYSED.NY

2000 To 2004 “Tech Sample – Generalist (ASCP)

1995 “Axsym Exe.” Abbott Diagnostics, Dallas, Texas

1993 ‘CMLTO- Registration. Biochemistry & Bacteriology. Toronto. Ontario

1992 “Clinical Chemistry Part 1 & 2, Southern Alberta Institute of Technology, Calgary, Alberta.

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