CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "fda "

Clinical Research - 8 Years of Experience - Near 60169

Professional Summary A certified professional Clinical Research with 4 years of experience in Clinical Research coordination and a year experience as Clinical Study Associate. Expertise in QC of documents, remote Monitoring and supporting the management by handling the tasks of multiple clinical research studies managing eTMF's & designing Clinical Portfolio's from Sponsor end. Expert in liaising between different departmen...

Tags for this Online Resume: Document Management, Monitoring - Remote and onsite, Clinical Research coordinator, Device trials, clinical Research, Project Management, QC and QA, Pharmacovigilance, Ethics and compliance, regulatory, Clinical study Associate, Multiple therapeutic areas experience, Phase 1-4 trials, Audits and Inspection readiness, Multiple software and application experience - Veeva VAULT , Impact , Quest , Sentinel,Tesla, EDC experience- RAVE Medidata, IRT system experience Clinpace , Endpoint

Industrial Engineer

Qualifications of a Senior Industrial Engineer/ Project Engineer Dynamic results-oriented Senior Industrial Engineer with experience in product launch, pharmaceutical regulations, project management and development and execution of projects. Decision maker capable of making analytical judgments to drive the attainment of growth objectives through leadership and solving problem skills. Highly motivated by challenges and dedi...

Tags for this Online Resume: Management, Documentation, Manufacturing, Business Plan, Compaq Alpha, Corrective Actions, English Language, Good Manufacturing Practices, HR, Human Resources

Director

SUMMARY OF QUALIFICATION * Extensive experience in FDA regulatory requirements (GMP, CFR) and ISO standard regarding Medical Device, Pharmaceutical, Skin Care, and Food Industry * Extensive experience Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma 5S, and SPC to assure efficient process and high product quality product * Extensive experience in managing the Supplier/ Vendor qualification program, Supp...

Tags for this Online Resume: Extensive experience in CAPA, Extensive experience in IQ/OQ/PQ VAlidation, Extensive experience Quality audit, Extensive experience Supplier Qualification, Extensive experience FDA and ISO Regulatory, Extensive experience Process and Quality improvement, Extensive experience Reducing customer complaint, Scheduling, Chemistry, Good Manufacturing Practices

Quality Assurance Specialist - 13 Years of Experience - Near 94506

SUMMARY Proficient in developing and applying Software Quality Assurance techniques and strategies to resolve problems in software and compliance with FDA regulation and ISO guidelines in Agile software development environments. Applied SQA principles and methodologies in Manual and Automated Testing with Real Time instruments. Tested instruments Firmware and Drivers. Created, modified and executed test plan and test cases....

Tags for this Online Resume: Real Time Instruments, Test Case Development, FDA, ISO standards, Visual Studio Test Management, Manual and Automated Test, Agile software development, TFS, TestTrack, C#, Python, Troubleshooting, Medical Devices Firmware, Drivers, 21CFR Part 11, Life Science, Data Analysis

Materials Scientist - 20 Years of Experience - Near 27597

SUMMARY Seeking Challenging Scientific /Engineering role with Chemical Engineering, Business Management degrees and 25+ years experiences in process/project/manufacturing/quality engineering in Fortune 500 companies in the United States. * Excel in process technologies for extrusion & molding of plastic & rubber manufacturing. * Experienced (hands on) in: Medical Equipment, Automotive, Rubber Compounding, Plastic, Glass, Fl...

Tags for this Online Resume: Heat Exchangers, Product Development, Corona, Quality Assurance, Engineering, Green Belt, Injection Molding, ISO, Medical, Plastics

System Engineer - 6 Years of Experience - Near 98073

CAREER HIGHLIGHTS * Connected things and people through Wi-Fi, Bluetooth, and Cellular to help provide information to enhance life through biometrics, auto-ordered products, and cardio monitoring. * Bringing people back from the dead by guiding a team to create the most advanced Automated External Defibrillator (AED) by Architecting, Designing, and coding the software. Product in use. * Saving lives and limbs by resolving b...

Tags for this Online Resume: Software, Systems Engineer, C++ Programming Language, Microprocessors, Troubleshooting, Management, Project Management, Project Manager, Radar

Administrator - 20 Years of Experience - Near 20016

AREAS OF EXPERTISE * Project Management * Conference Coordination * Leadership * Budget/Accounting * Training/Education Management * Administration * Strategic Planning/Analysis * Organizational Compliance * Logistical Support * Team Coordination * Collaboration * Analytical Thinking PROFESSIONAL E XPERIENCE FOOD AND DRUG ADMINISTRATION, OFFICE OF INFORMATION TECHNOLOGY JUNE 2015 - NOVEMBER 2015 WHITE FLINT, MD (POSITION VI...

Tags for this Online Resume: Management, Accounting, Acquisitions, Budgeting, Compliance, Information Technology, Leadership, Planning, Procurement, Project Management

Customer Service Manager - 5 Years of Experience - Near 43619

regulatory agencies such as the FDA. Building relationships and acting as an internal liaison for my assigned clients by providing complaint resolution and project management. Facilitating communications between clients and NAMSA associates to ensure that studies are completed for clients to make their regulatory deadlines. Additional skills include sales demonstrated communication excellence and a drive for continuous impr...

Tags for this Online Resume: Management, Toledo, Ohio, Customer Relationship Management, Facilitator, Project Management, Quality Assurance, Medical devices, Client Satisfaction

Pharmaceutical Scientist

SUMMARY * Scientific Leadership-Pharmaceutics. Wealth of experience (>25 years) in delivering impactful products to the market through Formulation/Process development (solids, liquids, and parenteral dosage forms) and Analytical development. Key example: Lexapro marketed by Forest. * Organizational Leadership and Mentor. Scientific organization management that focused on learning and delivering results. Underlying philosoph...

Tags for this Online Resume: Management, Business Development, Documentation, MOS, Pharmaceutical, Due Diligence, Manufacturing, Packaging, Process Improvement, Quality

Clinical Research - 10 Years of Experience - Near 20895

SUMMARY: International work experience in Pharmacovigilance, Clinical Trials, Pharmaceutical Sales and Regulatory Affairs encompassing Phase I experimental trials through post marketing safety reporting for the National Institutes of Health and for major pharmaceutical companies. Accomplishments include: Work Instruction Manual on Data Reconciliation for Astrazeneca. Led a team of six in writing the Work Instruction Manual ...

Tags for this Online Resume: Team Lead, MedDRA, RN, Acquired Immune Deficiency Syndrome (AIDS), oncology, Drug Safety Monitoring, Quality Assurance, Quality Control, Clinical Research Support, Data Management, Pharmacovigilance, FDA Reporting, IRB, International experience, Product Launch

Production Manager

Career Focus Accomplished Production Manager and Supply Chain Management professional with an MBA and over a decade worth of experience in the medical device industry. Highly motivated to apply my skills and experience in a new management opportunity with upward mobility. High level of focus on providing value solutions through Customer or supplier relationship building.

Tags for this Online Resume: Management, Central Supply, Engineering, Manufacturing, Packaging, Plastics, Process Engineering, Project Management, Audit, Clean Room, Medical Device, FDA

Medical Scientist - 2 Years of Experience - Near 55369

Summary of Key Qualifications I am a highly motivated, independent scientist with a wide range of scientific and clinical interests. I can offer: (1) experience in industrial collaboration and working with key stakeholders in academia and industry, (2) an understanding of the drug development process and FDA regulations for MSLs, (3) 10+ years of scientific training, with flexibility across different therapeutic areas (e.g....

Tags for this Online Resume: MSL, Medical Science Liaison, Medical Affairs, KOL, Biotech, Pharmaceutical, Communication, Teaching, Networking, Project Management, Independent, Cell Biology, Oncology, Neurology, Cardiology, Gastroenterology, Endocrinology, Northwest, California, Midwest, United States, Northeast, Field, Travel, FDA, off-label, business acumen