CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA "

Waste Treatment Plant Operator - 3 Years of Experience - Near 98506

Seeking a position in an organization where I can further develop my skills and knowledge to benefit myself and the organization or agency. CORE QUALIFICATIONS * Excellent knowledge of the FDA and USDA regulations and laws concerning food safety and sanitation precautions and requirements * Excellent communication skills both oral and written * Able to conduct audits of food preparation and sanitation * Sound understanding ...

Tags for this Online Resume: Quality Assurance, Test, Quality Control, Utilities

Clinical Regional Monitoring

Therapeutic experience in IVD Oncology Hematology Orthopedics GI Cardiology Melanoma ENT Multiple Sclerosis and ADHD Extensive knowledge of FDA regulations ICH guidelines GLPs GCPs and SOPs * Monitoring experience of national and international sites for PSSVs SIVs IMVs and COVs * Ability to identify issues and resolve appropriately * Experience multiple EDC systems and platforms

Tags for this Online Resume: Accounting, Policies and Procedures, Project Management, Project Manager, Protocol, Documentation, Cardiology, Clinical Research, Orthopedics, Research

Clinical Research - 3 Years of Experience - Near 02478

Summary: MS in Clinical Investigation with 3+ years of experience as Clinical research assistant cum coordinator seeking a preferably full time position in Clinical Research fields as Clinical Trial Associate / Project Management. Offering combination of strong background in biological sciences (specialization in Oncology, Molecular biology) as well as deep understanding and knowledge of ICH-GCP & FDA regulations. Demonstra...

Tags for this Online Resume: Clinical Research, Documentation, Research, Advertising, Audit, Budgetary, Data Entry, Data Management, Filing, Gastroenterology, Recruting, IRB admministration, regulatory, phase ii, clinical trials, ICH-E6 GCP and GLP, HIPAA compliance

Chief Operating Officer

Professional Summary: Skilled in Medical Device Field, Mergers & Acquisitions, Start-ups, Healthcare Research, with strong communication (oral and written) skills -, multi-tasking, project-management skills, research writing, fund-raising presentations, plus other outstanding professional qualities. and * Spent over 10,000 hours in developing the company's prototype. * Implemented a pilot study at a Boston hospital for medi...

Tags for this Online Resume: Equity, Medical, Research, Clinical Research, Start-ups, Hedge Fund, Securities, Series 7, Investment Opportunities, Acquisitions, outside sales, business development, marketing, account executive, technical sales, management, sales

Biomedical Engineer - 17 Years of Experience - Near 92604

Summary R&D Team Leader and engineering professional with extensive experience in the medical device industry, and strong academic background. Expertise in product development, risk assessment, CAD, Solidworks, test method validation, design control, biomaterials, tissue biomechanics, clinical studies, plastics, and finite element modeling. Key strengths include management, problem solving, innovation. Hands-on troubleshoot...

Tags for this Online Resume: MCAD Solidworks, Risk Assessment, Manufacturing, E3, ISO, Research and Development, Surgery, Surgical, Development Activities, PEDIATRIC, mechanical engineering

Chemist - 20 Years of Experience - Near 10605

Tags for this Online Resume: CMC, Regulatory, Pharmaceutical, Drug development, FDA, Medical Device

Technical Manager in Manufacturing- 11 Years of Experience - Near Salt Lake City, UT

Seeking Operations or Sr. Engineering Manager position. Methodical, innovative, and results-driven leader with hands-on experience in regulated and non-regulated industries, focusing on strategic planning and operational excellence. Effective at developing and implementing strategies to attain set-forth business key performance indicators (KPIs), maximize growth opportunities, and streamline processes and company operations...

Tags for this Online Resume: Manufacturing, Reliability, Process Improvement, Instrumentation, Matlab, Troubleshooting, Complaints, Data Analysis, Diagnostic Tools, Ethernet

Quality Assurance Director - 11 Years of Experience - Near 07076

SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...

Tags for this Online Resume: Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development

Chemical Engineer

PROFILE project management and handling instruments/equipment * Good understanding of various chemical processes (Distillation, Heat Transfer, Fluid Mechanics, Chemical Reaction Kinetics) * Excellent knowledge in ISO Standards, FDA guidelines 21 CFR Part 11, Part 210, Part 211, SOP, cGMP, cGLP, Audit trails, GAP Analysis * Familiar with safety protocols followed in research labs and worked on projects/assignments related to...

Tags for this Online Resume: Statistical Analysis, Audit, Autocad, Autodesk AutoCAD, C Programming Language, CFR Part 11, Corrective Actions, Green Belt, HAZOP, HTTPs

Chemist - 20 Years of Experience - Near 12122

Profile: Experienced Analytical Chemist * Self-motivated, result driven, detail oriented individual, works well as a team member or independently, willingness to learn * Strong background in GMP/GLP, analytical and wet chemistry * Well-versed in USP, EP and JP policies and procedures, chemical hygiene and safety policies * Analysis and release of raw materials, finished products, in process, and stability samples * Method d...

Ideal Companies: Pfizer, GlaxosmithKline, Astrazenica

Tags for this Online Resume: Audit, Documentation, Kaizen, Management, Packaging, Quality, Quality Assurance, Quality Control, EP, pharmaceutical, Quality control, Laboratory, analytical, chemist, GMP

Chemist - 11 Years of Experience - Near 75002

To provide my expertise for companies in need of support with R&D, quality control and regulatory. * Qualities Highly detailed and dedicated person, fast learner strong leadership skills proven orga - nizational and management skills and self - motivated. A team player and performs well under pressure. Fields of experience include but are not limited to Microsoft Office Word, Power Point and Excel, SharePoint, Visio, Adobe ...

Tags for this Online Resume: Audit, Medical, Regulatory Affairs, Complaints, Product Development, Chemistry, Market Research, MSDS, Research, sas, oncology, phase, gcp, 6 sigma, SOP, R&D, Cosmetics, Drugs, FDA, QC

Department Manager - 20 Years of Experience - Near 66210

SUMMARY My name is Bill Christian. My entire career has been in Maintenance Engineering with 26 years as either a Plant, Chief or Regional Engineer. Most of my career has been in Alaska where the remoteness translated to a lack of outside contractors. Production was seasonal which required an immediate and accurate response to all situations and emergencies. Listed below are my most recent experiences. I look forward to dis...

Tags for this Online Resume: Budgeting, Cardiopulmonary resuscitation (CPR), CAT, Control Systems, Engineering, Hydraulics, Occupational Safety and Health Act, OSHA, Power (Os Enhancemnt Tool, Root Cause Analysis, maintenance, "project management", production, mechanical engineer, manufacturing