Laboratory, GMP, Troubleshooting, Validation

SUMMARY

Experienced Clinical Laboratory Technologists with Immunoassay, Hematology, Blood bank, Coagulation and Clinical Chemistry experience.

Experience with writing, executing and approving IQ, OQ and PQ protocols.

Performed validation/verification studies on IVD medical instruments such as Dimensions EXL 200, VISTA 500/1500, IMMULITE and Atellica at Siemens Healthineers diagnostics.

Excellent communication skills with expertise in MS word, MS Excel and MS power point.

Presented power point presentation at state level.

Resolved CAPA issues and Non conformances.

Experience setting up the new instruments and served as a representative to explain the operation of the new instrument to the laboratory staff, supervisors, and managers.

Knowledge of GDP, GMP and 21 CFR.

Experienced phlebotomist.

EDUCATION

Aug 2009 – Sept 2012

Master’s in clinical laboratory science (MS – CLS, GPA – 3.98) Long Island University, C.W. Post, New York (NAACLS Accredited)

Jul 2005 – May 2008

Bachelors in Clinical Laboratory Science (B.Sc - CLS)

S.N.D.T. Women’s University, Mumbai, India

Jul 2002 – May 2005

Diploma in Medical Laboratory Technology (DMLT)

S.N.D.T. Women’s University, Mumbai, India

PROFESSIONAL EXPERIENCE

Jan 2021 – present

Lead Biochemist

August 2020 – December 2020

Validation Technologist

April 2013- July 2016

Medical Laboratory Technologist

Working as a Biochemist in R & D department at Siemens Healthineers in Flanders NJ.

Enhanced testing accuracy by performing validation/verification testing and executing IQ, OQ & PQ protocols for In vitro medical device instruments such as Atellica and Immulite.

Responsible for daily, monthly, and annual maintenance on multiple instruments.

Filled in the role of a support engineer for instrument repair due to lack of onsite support engineer.

Troubleshot instruments and replaced parts to execute R&D studies.

Advanced skills and efficiency by receiving training on final product testing at the manufacturing site.

Running the controls, calibrators and approving the data.

Streamlined instrument maintenance and qualification process by creating log sheets, ordering consumables and reagents, and analyzing qualification data for submission.

Ordered consumables, reagents and stocked in the appropriate environment.

Performed qualification testing and requalified the instruments upon their relocation.

Supported feasibility, validation, and verification studies in R & D lab.

Diagnosed and repaired IVD medical instruments. Replaced faulty/expired parts such as aspirating syringe, leaking filter, sample cuvettes, syringe arm.

Ensured data integrity and compliance with GxP, safety, and environmental requirements through accurate data capture, entry, and maintenance of laboratory notebooks and detailed records.

Maintained optimal instrument performance through daily, monthly, and annual maintenance, and ensured instrument readiness by requalifying them post-relocation.

Worked as a Validation Technologist at Quest Diagnostics Clifton, NJ facility, one of the largest clinical laboratories in United States.

Key operator on Sysmex XN line, Siemens CS-5100, Coagulation analyzer, Architect C8000, Mechatronics Starrsed for ESR, Optilite and AUWi PRO. Ensuring the analyzers perform to the highest standards.

Performing in depth precisions, correlations, linearity studies, dilutions, LOQs, carryovers, reference intervals, stability studies and entering that data into SharePoint for validation.

As a lead technologist, led a team of Technologists and provided training in proficiently performing testing, running various automated devices with minimized errors. Working with technicians at other Quest facilities in preparation for the move to Dream Clifton.

Worked as a Medical Technologist at Mount Sinai Medical Center in the Department of Hematology and Coagulation.

Have an experience working on a Beckman Coulter line and analyzer, instrument start up, running latron, and controls, running the coagulation line and Diagnostica Stago analyzers, and doing weekly maintenance. Reading differential slides, body fluids, and urinalysis. Experienced working in the department of special coagulation doing factor assays, mixing studies, and platelet aggregation studies.

Executed analysis using HPLC and SDS gel electrophoresis.

Jan 2010 – Dec 2011

Chemistry Laboratory Assistant

Long Island University, C.W. Post, New York

Sep 2010 – May 2011

Graduate Assistant for Clinical Chemistry and Medical Microbiology

Long Island University, C.W. Post, New York

Nov 2008 – Jun 2009

Teaching faculty for Clinical Laboratory Science

S.N.D.T. Women’s University, Mumbai, India

Jun 2008 – Oct 2008

Laboratory Technician in the Dept. of Clinical Pathology, Hematology, Clinical Biochemistry, Microbiology, Serology

Dr.Pendharkar’s Laboratory, Mumbai, India

Apr 2004

Attended a CME on First Update in Lipids held at P.D. Hinduja National Hospital and Medical research Centre, Mumbai, India

HONORS AND AWARDS

November 2012 Achieved highest score in ASCP certification at Long Island University – New York

Feb 2009

Awarded Kamal Babaji Godkar award for securing highest rank in Bachelor of Clinical Lab Science at the 58th Annual Convocation - India

PROFESSIONAL MEMBERSHIPS

American Society for Clinical Pathologist (ASCP)

LICENSURE AND CERTIFICATION

ASCP certified

New York State Licensure

INTERNSHIP EXPERIENCE

Jan – Feb 2012

Hematology and Coagulation

South Nassau Communities Hospital, Oceanside, New York

Feb – Mar 2012

Blood Bank

Winthrop University Hospital, Mineola, New York

Mar – Apr 2012

Microbiology

Southside Hospital, Bay Shore, New York

Apr – May 2012

Clinical Chemistry

St. Francis Hospital, Roslyn, New York

May – Jun 2012

Clinical Immunology

Sunrise Laboratory, Hicksville, New York

North Shore LIJ Core lab, New Hyde Park, New York

Jan 2008 – Apr 2008

Completion of course in Human Cytogenetic - Wellspring Laboratory, Center for Genetic Health Care, Mumbai, India

Jul 2007 – Apr 2008

Training program in Biochemistry, Hematology, Microbiology, Immunology - Dr.Amin’s Pathology Laboratory, Mumbai, India

Jan 2007 – Apr 2007

Internship in the Dept. of Biochemistry, Microbiology, Hematology Oncology, Pathology, Cytology, Transfusion Medicine - Tata Memorial Hospital, Mumbai, India

Dec 2004 – May 2005

Internship in the Department of Biochemistry, Microbiology, Hematology, Histopathology, Immunology, Transfusion Medicine - Jaslok Hospital, Mumbai, India

REFERENCES

Available upon request.

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