Project manager,chemist,chemical engineer

*** ******** ****** 908-***-****

Elizabeth, NJ **202 ********@*****.***

Hiral Sheth

Objective To obtain a position in an environment where skills and knowledge of biomedical science and chemistry will be challenged daily.

Education University of Medicine and Dentistry, Stratford, NJ

M.S. in Biomedical Science expected December 2011

Rutgers University, Newark, NJ

B.A. in Chemistry earned May 2007

Completed American Chemical Society Certification

Qualifications

and Skills

Extensive knowledge of working with cGMP, cGLP, GDP and standard operating procedures.

Extensive knowledge of FDA regulations regarding biomedical instruments.

Proficient in MS Word, Excel, PowerPoint, Access, Publisher and Adobe Acrobat.

Excellent communication and collaborative team working skills.

Strong technical and problem solving skills.

Work

Experience International Technidyne Corporation; QC Technologist & Team Leader

Edison, NJ November 2007 – Present

Conducting quality control testing on raw materials, in-process products and finished products.

Routine and non-routine analysis of medical devices and cuvettes for product release.

Performing validations on revised and new products to assure proper function and accuracy during testing.

Analyzing and investigating instrument errors, faults and failure rates at different stages of testing to release only acceptable product.

Reviewing and releasing product related data and writing quality control reports.

Training new technologists on finished products using standard operating procedures.

Organizing Biomedical QC Lab to maximize efficiency and effectiveness of releasing products to the market.

Develop, review and revise Standard Operating Procedures (SOP) to ensure accuracy of procedure to current practices.

Applying ECO’s and TECO’s to make changes to current SOP for a more effective process.

Working on innovative Test Method Validations (TMV) for medical devices and cuvettes to enhance current processes.

Working on LSR projects to detect and limit amount of errors occurring with devices and cuvettes.

Performing engineering studies to ensure effectiveness of medical devices.

Preparing reagents and solutions in support of laboratory testing.

Ensuring appropriate levels of supplies and equipment is maintained at all times in the lab.

Performing data entry for appropriate Quality and Oracle databases.

Initiate and conduct Out of Specification (OOS) investigations on ITC products.

Accutest Laboratories; Organic Chemist

Dayton, NJ June 2007 – August 2007

Performed organic and inorganic analyses of water and soil samples collected in support of regulatory and industrial programs.

Collected analytical data from automated instruments via LIMS.

Performed all testing under strict compliance with project specific data-quality objectives.

Center for Molecular and Behavioral Science, Rutgers University; Lab Assistant

Newark, NJ April 2005 – May 2007

Prepared volatile and non-volatile solutions for various experiments.

Performed in-vitro experiments to analyze GABAergic neurons in transgenic and wild type mice.

Used a variety of staining methods to trace GABAergic neurons in brain slices

References Available upon request.

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