Quality Assurance Medical Device
Resume:
RITA SURANI
Long Grove, IL *0047
Cell 224-***-**** **********@*****.***
Results oriented, achievement-driven Advanced Quality Technician seeking position in FDA
regulated Medical Device, Pharmaceutical, Biotech industry.
QUALIFICATIONS
Over 15+ years experience in medical device and pharmaceutical industry as Advanced
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Quality Technician.
Expertise in performing in-process and final release testing utilizing Analytical and
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Organic Chemistry Laboratory instrumentation.
Areas of expertise – Quality Assurance, Quality Control, Validation, Stability Studies and
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Laboratory Auditing.
Selected as a lead member for R&D projects to perform design verification and validation
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studies.
Proven strengths in meeting deadlines, prioritizing, testing, organizing, analyzing and
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training.
Multi-lingual.
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PROFESSIONAL EXPERIENCE
ABBOTT LABORATORIES, Abbott Park, IL 1999-2014
Advanced Quality Technician
Performed quality testing for medical diagnostic immunoassays on automated platform,
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which provided in-process analytical results for life cycle of product.
Performed analysis of data using Microsoft Excel, WWLIMS and MpSmplr1 to generate
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advanced user of Laboratory Information Management System (LIMS), Online, offline
and user interface systems, Standard Operating Procedures (SOP) resulting in providing
valid information about assay improved product decisions.
Investigations of Out Of Tolerance (OOT) during in-process testing prior to final release
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testing of newly manufactured products while providing Event Data Collection (EDC)
reports to ensure product availability.
Extensive use of Corrective and Preventive Action (CAPA), Statistical Process Control
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RITA SURANI
4481 Normandy Court
Long Grove, IL 60047
Cell 224-***-**** **********@*****.***
(SPC) and internal Materials Management SAP system to ensure quality and compliance
with regulatory requirements.
• Recognized as the Expert Trainer for Quality Test Auditing procedures for in-house
production and stabilities.
• Resolved customer complaints within time limit, achieving customer satisfaction and
smooth transition of on “Market products”
ABBOTT LABORATORIES, Abbott Park, IL 1993-1999
R&D Technician (MANPOWER)
Performed R&D studies for development of Cardiovascular assay by evaluation and
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assessment of preliminary stability of reagents.
Evaluated the hepatitis assay developmental reagent lots for sensitivity and specificity,
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precision and cross contamination studies.
EDUCATION
MASTER OF SCIENCE, Organic Chemistry, Gujarat University, India
BACHELOR OF SCIENCE, Chemistry, Gujarat University, India
SUMMARY OF SKILLS / CERTIFICATIONS
PROFESSIONAL DEVELOPMENT
• Quality system Regulation
Statistical Process control
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Corrective and Preventative Action
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Design Verification and Validation
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In-Process and Final Release Testing Certificate for all ARCHITECT and AxSYM
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products.
REGULATORY & COMPLIANCE
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RITA SURANI
4481 Normandy Court
Long Grove, IL 60047
Cell 224-***-**** **********@*****.***
• Current Good Manufacturing Practices (cGMPs)
Good Laboratory Practices (GLPs)
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FDA 21 CFR 820
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COMPUTER COMPETENCY
• MS Word and MS Excel
Laboratory Information Management System (LIMS)
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Electronic Laboratory Notebook
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INSTRUMENTATION
• Automated Immunochemistry System (Abbott’s ARCHITECT Analyzer)
Automated Immunoassay System (Abbott’s AxSYM Analyzer)
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