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FDA resumes in New Haven, CT

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Management Engineer

Southbury, CT
... • Applications Development Expert • Automation Regression Expert • FDA CFR 21 Part-11 • Unit Testing • SDLC, Change Management • Quality Assurance and Best Practices • Functional Testing • Requirement Analysis • Development & Gap Estimates EDUCATION ... - 2015 Nov 30

Medical Technologist Manager

New Haven, CT
... July 2011-August 2012 Part-time days performing Chemistry tests on patient samples to qualify studies in Clinical trials to obtain FDA approval on test kits and some instruments for diagnostic testing. Part-time running PCR to qualify a new test for ... - 2015 Oct 04

Sales Customer Service

Branford, CT
... Highly knowledgeable and practiced in achieving compliance on OSHA, FDA, NRC, DEEP, DEA and ISO’s as well as local, state and federal safety requirements, regulations and guidelines through the development of robust quality programs. A respected ... - 2015 Jun 10

Development Management

Newtown, CT, 06482
... Knowledge of cGMP's/GLP's, DEA regulations, ICH, FDA CMC guidance documents . Working knowledge of a document management system Technical Experience: . Direct the overall scientific, technical and laboratory efforts of the Analytical Development ... - 2015 Apr 01

Quality Management

Redding, CT
... com http://www.AquaMarineGroup.com PROFILE A uniquely interdisciplined individual, melding comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials. ... - 2014 Nov 12

Marketing Management

Milford, CT
... June 2013 August 2013 Pipeline Intern Was part of a team tasked to develop a campaign including insight, strategy, creative concepts and executions of • ideas to present to the FDA for the launch of new anti-smoking ads • Worked as an associate ... - 2014 Sep 23

Research Chemist

New Haven, CT
... SHRAGIS ** Vernon Court W oodbridge, CT ***25 203-***-**** acfurs@r.postjobfree.com www.linkedin.com/pub/eva-shragis/19/922/909/ PROFESSIONAL PROFILE : NDA Submissions Report Writing IND applications Pharmacokinetics Training & Education FDA ... - 2014 Sep 09

Customer Service Administrative Assistant

Bridgeport, CT
... • Created annual reports on research and marketed products for IND/NDA submission to FDA. • Assembled reports and associated documentation for regulatory filings. • Conducted literature research. - reviewed summary of information • Assisted with ... - 2014 Sep 02

Engineer Project Manager

Hamden, CT
... year • Created and commercialized Fixt™ Introducer • Authored component / product qualifications in preparation of FDA submission • Design Council Facilitator • Supervised / Mentor design team personnel and other staff in support of project goals. ... - 2014 Aug 09

Customer Service Representative

Oakville, CT
... Newark NJ 07106 Telephone: 973-***-****) cell: 973-***-**** SUMMARY: Goal oriented and result driven professional with knowledge of Pharmacovigilance, ICH-GCP,GLP and FDA/EU regulations in Pharmaceuticals and Biotechnology operational settings. ... - 2014 Aug 09
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