CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "fda "

Lead Developer - 17 Years of Experience - Near 08833

Professional Summary Accomplished software developer and team lead with full software development lifecycle (SDLC) and varying industry expertise pursuing a challenging technical lead/development position at an organization that inspires professional and personal growth. Project summary - Technical lead for the Digital IT Marketing Operations team o Co-ordination liaison between onsite and offshore technical resources o Sup...

Tags for this Online Resume: Microsoft, Industry experience (IT, finance, pharmaceuticals, government), .NET (C#, VB.NET), Active Server Pages, ADO.NET, Adobe, MVC, AngularJS, API Integration, SharePoint

Clinical Regulatory Affairs - 5 Years of Experience

Profile Regulatory Affairs Specialist with more than five years of experience in the pharmaceutical and biotechnology industries, implementing global regulatory filing strategies. Education in biotechnical engineering with deep knowledge and practical skills in managing the submission process from start to end, monitoring and tracking information, communicating with colleagues, managers and subject experts for efficiency an...

Tags for this Online Resume: Manufacturing, Packaging, Pharmaceutical, Regulatory Affairs, Biotechnical, Filing, Management, Medical, Medical Devices, Microsoft Office

ERP - 9 Years of Experience - Near 19341

Profile Lead Management for SAP Security and Compliance Strategies. Experience with all types of business, both Private and Public Sector, Manufacturing, but with a concentration in the pharmaceutical Industry. Work with both internal/external auditors, SOX audits requirements, along with FDA audits. Able to lead teams of various sizes. SAP Experience - Summary Project lead for Security and SOX Compliance for variety of SAP...

Tags for this Online Resume: User Administration, Audit, Information Technology, R3, SAP Security, SAP R3, Compliance, Monitoring

Electrical Engineer - 20 Years of Experience

SUMMARY OF QUALIFICATIONS Team leader for design and installation of electrical power, process automation and controls in power generation, commercial, public, chemical, mine/mill and manufacturing industries for 30+ years. Proactive in engineering design as well as construction, startup, maintenance and facility support. Experience in US, European, African and Latin American operations. * EPC of facilities with API, OSHA, ...

Tags for this Online Resume: Start up, EPC, Microsoft PowerPoint, Construction, Electrical Engineering, Engineering, ISO, ISO 9000, Microsoft Word, Project Management

Executive Assistant - 15 Years of Experience - Near 98058

Tags for this Online Resume: Microsoft Outlook, Training, Customer Accounts, Inventory, Surgical, Compliance, Health Care Industry, Executive Assistant, MDR, Excel, Patient confidentiality, Healthcare, HIPAA, Microsoft, Outlook, Patient Confidentiality, FDA, Audits, Surgical Instrumets, Scheduling, Calendaring, Inventory Software, Manager, Director of Operations, Manuafacturing Company, Sales

Maintenance Manager

SUMMARY Eight years of management experience in JIT, Lean, Six Sigma, SPC and 5S facilities. Exceptional problem solver with ability to manage departments and change. ISO 55001 Asset Management, ISO 9001, HACCP, and SQF training. Managed a maintenance and operations department budget of $70k per month. Advanced knowledge and implementation of proactive maintenance to institute reliability growth and implementation of TPM fo...

Tags for this Online Resume: Manufacturing, Troubleshooting, 5S, CNC, Management, Packaging, Electronics, Quality, Quality Assurance, Quality Control

Medical Scientist - 8 Years of Experience - Near 20854

Summary Research scientist with an excellent track record of productivity in R&D and regulatory (GLP/GMP) industry R&D experience (immuno-oncology) * Contributed to project completion for FDA IND filing by creating 8-10 stable antigen presenting cell lines, and 3 target lines to expand and test chimeric antigen receptor-modified T cells. * Optimized/Validated cell-based assays (proliferation, cytotoxicity, cytokine producti...

Tags for this Online Resume: Publications, Database, SoCs, Good Laboratory Practices, Good Manufacturing Practices, Communication Skills, Compliance, Corrective Actions, ELISA, Excellent track record

Business Analyst

SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...

Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11

Quality Coordinator - 10 Years of Experience - Near 08817

SUMMARY Highly knowledgeable and effective Operations professional with diverse industry knowledge and talent for searching out opportunities for improvement, contributing to cost reduction, increased productivity, and waste reduction. Excellent project management skills and strong track record of hiring and successfully developing team members. * Significant success in start-up and high growth operations, laying the ground...

Tags for this Online Resume: Engineering, Fabrication, Industrial Engineering, Support, Technical Support, Complaints, Logistics, P&L, Packaging, Project Management

Supply Chain Manager - 18 Years of Experience - Near 02370

PROFESSIONAL SUMMARY A logistics professional with expertise in all aspects of Distribution Operations. Strengths include implementation of warehouse management systems (WMS), compliance with all ISO, OSHA, FDA and GMP regulations, project management, implementation of ERP system (SAP R/3), site selection and warehouse consolidations and inventory control. Technical experience with Pick/Pack systems, Bar Coding and Scanning...

Tags for this Online Resume: Inventory, Inventory Control, Consolidations, Legacy, Management, Order Processing, SAP, SAP R/3, Site Selections, Warehouse Management

Clinical Project Manager-6 years-France

I supervised the development of several clinical projects in different therapeutics areas and in different countries (France, England, Italy, USA and Canada). I coordinated the clinical activities in respect with the budget, timeframe and regulations (SOPs, FDA-GCP and ICH guidelines). I trained CRAs, site investigators and CROs to ensure study protocol comprehension and compliance (initiation visits, co-monitoring). I plan...

Tags for this Online Resume: clinical project, oncology, dermatology, cardiology

Quality Engineer - 10 Years of Experience - Near 95127

SUMMARY Career highlights include building and directing a QA/QC function, Analysis, Testing, SPC project, Internal auditor in PWB high tech industry and Rechargeable Batteries of new technology (10+ years), Testing/Diagnose network systems to board level (5+years) & managing Analytical Labs in Food industry and Water Supply Sources (10+ years). Influenced on key committees and entrusted to manage the most confidential and ...

Tags for this Online Resume: Experience Auditor, Management experience, QA/QC profesional, Internal audit teamplayer, Microsoft Access profesional, Cisco system testing, Data Analysis Expert, Microsoft Excel professional, Microsoft Office profesional, NCR