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FDA resumes in Morris Plains, NJ

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Clinical Research Associate

Montville, NJ
... and site assessment Individual and large group training on EDC methods and best practices Liaison between sponsors, the FDA and research sites Responsibilities included a Phase III dermatology NDA, a pre-market maintenance study for a new ... - Apr 30

Information Technology Supply Chain

Morristown, NJ
... Strong understanding of IT Governance (SOX ITGC) for FDA and global/global regulatory audits. Excellent interpersonal skills to manage multiple priorities in a dynamic environment. Experience in ITSM tools such as ServiceNow to manage global ... - Apr 22

Supply Chain Senior Director

Hopatcong, NJ
... Supply Chain FDA inspection subject matter expert. • Created and optimized scheduling methodology for an immunotherapy product line. • Responsible for the development and maintenance of production schedules for both commercial and clinical products. ... - Apr 21

Case Manager Rn

Bayonne, NJ
... 2016 • Identify consumers of Johnson&Johnson bladder and hernia mesh recalls via medical charts for medical review to the FDA • Abstract patient information from medical charts such demographics, medical/surgical history and procedures before and ... - Apr 19

Development Operations Clinical

Jersey City, NJ
... Skilled in leading cross-functional product development programs and Clinical trial team management, specifically developing and implementing strategic product development plans, and ensuring compliance with FDA regulations and ICH guidelines. ... - Apr 16

Customer Service Rep

North Plainfield, NJ
... Dayton, NJ • Managed arriving vessels for spice company overseeing and serving as the company’s liaison • Handled the compliance of Customs regulations, in addition to coordinating with FDA and clearing Customs with Brokers • Generated purchase ... - Apr 15

Medical Courier Pick Up

Piscataway, NJ
... scales for weight verification, and calculators for accurate counts Strict adherence to SOP's which are in compliance with the FDA, CGMP, ISO regulations and company health and safety procedures This includes line clearances, set up of batch records ... - Apr 14

Product Development Quality Assurance

Irvington, NJ
... Skills Quality Assurance and Regulatory Compliance as per the relevant regulations Product Development ICHQ8R2, US FDA, WHO, EMA, MHRA Regulatory submission like CAPA reports, CTDs, monthly updates in inspection report response CAPA writing ... - Apr 07

Risk Management Data Architecture

North Bergen, NJ
... The entire software followed FDA regulations like PDMA and 21 CFR for sample validations rules. Environment: Oracle PL/SQL, C++, VB6, ASP, Sybase, HTML, JavaScript, XML, Perl Scripting, UNIX Shell Scripting. Sample Management as per CFR 21 Oct 1998 ... - Mar 31

Business Analyst Change Management

Iselin, NJ, 07067
... Good Automated Manufacturing Practices (GAMP 5) risk-based approach Provided Validation services in achieving the 21 CFR PART 11 (Electronic Records & Signatures) compliance to assure successful data quality and data integrity to, and FDA challenge. ... - Mar 28
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