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MarkDLevanites

Mark Levanites

Personal Information
Organization / Workplace
Greater Boston Area United States
Occupation
Business Development Regional Manager and Sr Consultant for Sequence Quality and Compliance Services
Industry
Medical / Health Care / Pharmaceuticals
About
Experienced professional with over 11 years of Computer Compliance, SQA and Risk Management experience in information technology and computerized systems for the Bio-tech/ Pharma/Med Device Industry (FDA regulated environment) Specialties Include: - IT Compliance (Infrastructure Validation, Enterprise Applications, Software Deployments, etc) - Software Validation for Databases/ Application Servers, Lab Systems, Clinical, Regulatory, etc - CFR 21, Part 11 Remediation (Electronic Signatures, Audit Trails, Security, System Administration, etc) - Authoring and execution of high quality SLDC documentation - Implementing guidelines and policies to comply with applicable regulations Systems Ex...
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