Manager Of Regulatory Affairs Resumes in New Jersey
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E Dow Location: Princeton Junction, NJ 08550 ... leigh Healthcare is a manufacturer and distributor of medical devices. The product lines include DVT Prophylaxis Equipment, Patient Transport and Positioning equipment and Handheld Dopplers. I am responsible for all functions within the Quality and Regulatory areas that are regulated under 21 CFR - Part820 (Quality System), Part 803 (Medical Device Reporting), Part 806(Medical Device Corrections and Removals) and Part 821(Medical Device Tracking). I also serve as the Official Correspondent to the FDA. The manufacturing sites were certified to ISO 13485. There was a harmonized system and approach to quality with all Huntleigh Healthcare globally throughout the world.FDA ActivitiesHuntle ...
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F Callihan Location: Clayton, NJ 08312 ... -site or single large site responsibility. Career Profile EXPERIENCED COLLABORATIVE EHS LEADER/ENVIRONME NTAL MANAGER with over 15 years experience in environmental, health and safety program development, implementation and management. I bring experienced, successful leadership in environmental programs, behavioral based safety programs and Six Sigma/Continuous Improvement programs. Ø Working in chemical manufacturing operations, pharmaceutical packaging and medical products. Ø Strong analytical, organizational and motivational skills that foster culture change in quality, productivity, environmental, safety and Six Sigma (Continuous Improve ...
95 hits
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H Patel Location: Somerset, NJ 08873 ... r Biotech Organization.Ove r 15 years of extensive Pharmaceutical industry experience in various capacities dealing with International regulations such 21 CFR Part 210, 211, 21 CFR 820, 21 CFR Part 11, EU-Annex 11, TGA-Annex11 regulations, ICH-Q7 and PIC/S guidance. Excellent experience in implementing & validating regulated Computer Systems and Processes for pharmaceutical and biotech companiesExtensi ve experience in managing regulatory Inspections performed by FDA, MHRA for new product releases, general cGMP audit and OOS failure investigations and CAPA. Detailed knowledge and experience in performing supplier audits of Information Technology based Quality systems, API providers, and ...
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R White Location: Glen Gardner, NJ 08826 ... ___ ____ SENIOR QUALITY CONTROL MANAGER Global Manufacturing / Multi-site Operations Performance / Reengineering I am a talented Operations Executive with eighteen years of experience in implementing best business practices for both manufacturing and retail operations for corporate and privately held businesses. EXPERTISE High-Performance Senior Manager experienced in supporting multi-customer quality assurance and compliance programs. Recognized for expertise in facilitating process change through training, direction, and motivation of operating staff and management teams. Managed quality assurance program in support of the President’s company-wide savings initiatives. Well ver ...
91 hits
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S Whitehorn Location: Phillipsburg, NJ 08865 ... Operational Excellence driven environments. Comprehensive understanding of cGMP methodologies coupled with process validation experience. Established record of excellence in Project Management and self directed leadership. Solid history conducting data collection, analysis, and design to optimize manufacturing processes. Extensive knowledge in the improvement of operational performance by utilizing Lean Sigma principals and Operational Excellence tools and methodologies to achieve business goals and targets. Demonstrated knowledge of transactional tools, including: Process Mapping, VOC, QFD, Pareto analysis, and cause/effect analysis. Motivated self-starter with good interpersonal and ...
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B Kelly Location: Cinnaminson, NJ 08077 ... ertified, Certified 2008Masters Certificate in Business Analysis, Certified 2007Certified Cognos Impromptu Administrator, Certified 2005IIBA Certification EligibleTechnica l Skills Operating Systems Mainframe: TSO/ISPF, AS400, Salesforce, IBMDatabases: Teradata, DB2 OS/390 v6/5/4, Microsoft Access 97/2000,2003,200 7Microsoft Office: XP, Office 2000, 97, 2007, MDMS, Informatica, DatastageProgram ming Languages: Cobol, C#, VB Script, Visual Basic, Structured Query Language (SQL), Microsoft SQL Server (2000, 2005)Web-based technologies: HTTP, JSP, SERVLETS, XML/SOAP, XSLT, Java application servers and J2EE containers (Web logic, JBoss, Apache, Tomcat), Salesforce, Apache Tomcat, v5.0,V5.5 ...
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R Sena Location: Flemington, NJ 08822 ... & financial scope with extensive Domestic & International success in China, Asia and Europe. Experienced in managing technical & production staff for New Product Development in start-ups and supply chain partnerships creating positive teamwork atmosphere and working relationships. Excellent in-depth knowledge in tooling, general manufacturing, China factory & QA for Manufacturing efficiencies and concurrent compliance management. Hands-on creator of directives, policies and procedures establishing an Organization’s “path forward”. Career Highlights Increased initial sales contracts up to 75% annually with client-specific presentations & negotiations. (Gunneson Group ...
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R Wimberly Location: Clifton , NJ 07011 ... ocesses for corporate initiatives. Experience in both executing and managing various steps of the product development process with major focus on Social Compliance and Quality Control. Results focused and team oriented management style. Experience 1993–Present Macys Merchandising Group New York, NY Director of Quality Assurance and Compliance Provide strategic plans and implementation for Quality Assurance and compliance program Apply production timeframes into both QA and compliance processes resulting in improved efficiencies in decision making process Develop and manage the criteria for monitoring the Code of Conduct requirements of Macy’s ...
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J Mostoufi Location: Sussex, NJ 07461 ... Optimization // Sterilization // Lean Manufacturing // CAPA // Six Sigma // ISO 9000 // Engineering, MBA Education.Design and execution of Operation systems to meet business, financial, regulatory and customer demands. Change agent and leader for an organization's journey toward Lean Enterprise Transformation. Experienced with unionized and non-unionized facilities. Demonstrated track record of strong, effective leadership for profitability, production, supplier management, quality, and safety. customer service and productivity improvement.CARE ER ACCOMPLISHMENTSU nion Tool & Molding Company - Operations / Quality Manager 2006- 2008Union Tool and Mold, A privately held Compan ...
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J White Location: Ewing, NJ 08618 ... t will utilize my experience in law, environmental, science and project management. EDUCATION: Boston University, Boston, MA 2008 Project Management Certificate Program New York Law School, New York, NY1996 Juris Doctor Howard University, Washington DC1983 Bachelor of Science Microbiology LEGAL EXPERIENCE: Contract Attorney, New York, NY, 10/05-Present Research, analyze and code legal documents and create reports for various law firms in preparation for litigation. Utilize Applied Discovery, Zantaz, Lexis/Nexus, Concordance and other electronic discovery software. Office of the Public Defender, Trenton, NJ1/03-9/05 Assistant Deputy Public Defender/Law Guardian Represented children in ...
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