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Online Resumes with "FDA"
Clinical Regulatory Affairs - 6 Years of Experience - Near 92648
QUALIFICATIONS Document-Labeling Specialist, Nov.2015 - Feb.2016 Well-versed communicator, high organizational and analytical (Contract Position Only) abilities. Work well independently and as a member of a * Creation, Revision of CGL, pre-printed labels and IFU via team. Adept in SUSARs, IRB submissions, Sponsor redlining documents and SOP standards. monitoring, and CTMS files. Efficient at handling multiple regulatory doc...
Tags for this Online Resume: R programming, Word, Excel, Adobe Photoshop, Illustrator, google analytics, github, Adobe, Data Entry, Documentation, ISO
Purchasing Agent
Profile Motivated, personable business professional with a successful 23-year track record of profitable procurement, management and lean logistics. Talent for quickly mastering technology. Diplomatic and tactful with professionals and non-professionals at all levels. Accustomed to handling sensitive, confidential records. Demonstrated history of Lean Manufacturing, J.I.T ordering, variety of procurement systems BPCS (MRP),...
Tags for this Online Resume: BAR, Purchasing, Test, Analytical Skills, Corrective Actions, Forecasting, Integrate, Inventory, Inventory Control, Inventory management
Clinical Research - 15 Years of Experience - Near 75089
I have been doing contract work For the last 2 years In house site audits Getting site ready for FDA audits
Tags for this Online Resume: Management, Project Management, Documentation, Training, VITAL SIGNS, Protocol, Audit, Banking Industry, Best Practices, Biomedical Industry
Contract Medical Writer
Summary Work Experience: Strong background in medical writing and biotechnology product and services development, with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise, analytical skills, data analysis, management experience, and medical knowledge. Participate in pre-clinical, clinical, and commercial research...
Tags for this Online Resume: Business Development, Cancer, Clinical Research, Medical Writer, regulatory science, biologics, drugs, medical device
Department Manager
Qualifications Profile Seasoned, highly effective, and dynamic cross-functional leader, offering comprehensive experience in lean manufacturing and engineering operations, project management, and research and development (R&D) across the science and technology fields. * Performance-focused and armed with tactical leadership and exceptional organizational capabilities in managing teams toward the successful and timely comple...
Tags for this Online Resume: Research, Chemistry, Science, Analytical Chemistry, Budgeting, Compliance, DSC, Engineering, Good Laboratory Practices, Good Manufacturing Practices
Quality Assurance Director - 18 Years of Experience - Near 55379
Summary of qualifications Global Quality System and Regulatory Compliance Experience in Regulated Environments (Medical Device/Pharmaceutical/Food/In-Vitro Diagnostics) including implementation of design controls * Global Regulatory and Quality Compliance (creating processes for Field Actions/point of contact for all recalls with the FDA/806 and monthly reporting) * Regulatory partnering with FDA and International Agencies ...
Tags for this Online Resume: Documentation, Infrastructure, Management, Program Management, Budget Preparation, Budgeting, Development Activities, P&L, Product Development, Project Management
Quality Manager - 12 Years of Experience
Professional Summary Self-motivated, energetic and effective leader with 13+ years of experience (8Years of leadership/managerial role) in quality assurance in pharmaceuticals, biologics, Complex injectables, Oncology and combination products. Proven to successfully design and implement quality systems and drive positive change in fast paced environments. Decisive leader who will apply initiative and innovation to establish...
Tags for this Online Resume: Management, Oncology, Manufacturing, Quality Assurance, Test, Quality, Quality Management, Documentation, Audit, Filing
Electronics Engineer
PROFESSIONAL SUMMARY o Prioritizing and multitasking as and where necessary in fast paced startup along with hands on experience in production line. o Experience in characterizing the antenna and tune it with the matching network elements. o Good experience in IEC 60601-1, IEC 60601-2-25, IEC 60601-2-47 for FDA flow, and ISO standard. o Hands on knowledge in setting up new evaluation modules as per requirement. Ability to r...
Ideal Companies: Aerotek, Raytheon, Eaton
Tags for this Online Resume: Biomedical Industry, CCS, Debugging, Documentation, Ideal, ISO, Packaging, Python Programming Language, Schematics, Security
Chemist
Responsible for training and mentoring junior chemist to perform complex testing of raw material by GC/MS. Effective organizational skills ability to multi-task and coordinate multiple activities. Performed instrument analytical method troubleshooting and problem solving. Knowledge of FDA regulations and compliance. Participated in Laboratory Investigations and Data Review. Interfaced with R&D and manufacturing department b...
Tags for this Online Resume: Manufacturing, Kaizen, Quality Assurance, Test, Forklift, Quality, Quality Control, Transmissions, Automotive, Documentation
Program Manager - 0 Years of Experience
Career Summary * Over a decade of experience as a Project Manager, primarily in the medical device industry, and inclusive of the following professional skills: * Project Management and New Product Development * Product Design & Engineering (for manufacturability, DFM) and Engineering Change Control * GMP, Good Manufacturing Practice, and Lean Six Sigma Manufacturing * Process Development and Statistical Process Control * I...
Tags for this Online Resume: Training, Billing, Change Control, Compliance, Documentation, Engineering, Management, Medical, Medical Devices, Process Control, manager, civil engineering, architecture, construction management
In Between - 5 Years of Experience - Near 500081
Career Summary * SAS Certified Base for SAS9 with more than four years of experience. * Worked on different Phases of clinical trials and I have experience in programming, SDTM, ADAM and reporting in Clinical Research using SAS environments. As a Clinical SAS * Worked on Various Complicated SDTM domains like LB, MO & OE for ophthalmoscopy studies * Understanding of the study Documents and Data (e.g. Study design and objecti...
Tags for this Online Resume: A SERIES, Active Directory Application Mode (ADAM), Base SAS, Cardiology, Clinical Research, Data Management, Documentation, Generate Reports, HyperText Markup Language, Macro (Predefined Code)
Sales Manager
Career Summary: * 10+ years of experience in Semiconductor Marketing Strategies and Sales, Field Operation, Product Management, Manufacturing, Technology Roadmap, Customer and Business Development. * 7+ years experience of research and development in field of: Semiconductor System, RF and Microwave Plasma Modeling, Wireless Device, Manufacturing Implementation, Sensory and Monte Carlo Statistical Simulation. * 3+ years expe...
Tags for this Online Resume: Support, Rf, Sales, Budget Control, Budgeting, Capital Equipment, Cardiovascular, Construct (App Dev Tool), Consultative Sales, Data Modeling
