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Online Resumes with "fda "



Supply Chain Manager - 20 Years of Experience - Near 11580

PROFILE * Professional with twenty + years of experience in international trade and customs compliance: managing people and processes, developing compliance strategies, policies, procedures, and related training * Highly skilled with US Rules, Regulations and documentation for import and export, and other government agency requirements (e.g., CBP, BIS, FDA, etc.) * Qualified in interpreting and applying foreign trade regula...

Tags for this Online Resume: Management, Distribution, Leadership, Audit, Audit Compliance, Compliance, Internal audit, Consulting, apparel, Assessments

Business Analyst - 12 Years of Experience - Near 30092

Tags for this Online Resume: Documentation, UI Design, Compliance, Process Improvement, SAS, Software, Software Development, Agile, AT&T, Business Analysis, agile, software, Project Management, Scrum Master, SDLC, OMS, WMS, FDA COmpliance

Clinical Research - 4 Years of Experience - Vancouver, B.C

HIGHLIGHTS OF QUALIFICATIONS * Over 4+ years of progressive work experience in clinical and academic research hospital settings, collaborating with investigators and a multidisciplinary health care team in the recruitment of study participants for various investigator-initiated and industry sponsored clinical trial studies. * Strong working knowledge of guidelines and policy governing clinical research and applicable regula...

Tags for this Online Resume: Protocol, Collection, COPD, Pulmonary, Scheduling, Specimen Collection, Amazon Elastic MapReduce, Applications, Assessments, Attention to Detail, cro, pharmaceutical, clinical trials, research, clinical, regulatory, phase i, phase ii, phase iii, phase iv

Automation & Control Systems Expert - 20 Years of Experience - Near 06375

QUALIFICATIONS Mr. Sincali has 30+ years experience in project design, programming, & commissioning of distributed automated control systems, electrical energy generation/monitoring/remote distribution control, CNG gas detection systems, pharmaceutical batch processing, paper/pulp mills, water/wastewater treatment SCADA and other advanced process control system applications. Recently, he has successfully implemented many la...

Tags for this Online Resume: Consulting, CT, Ethernet, Pharmaceutical, Automation, Assessments, CFR Part 11, Customer Accounts, Engineering, Hazardous Waste, distributed control systems, expert in PLC, control systems, project engineering

Production Supervisor - 20 Years of Experience - Near 92555

SUMMARY OF QUALIFICATIONS AND SKILLS: * Bilingual- English & Spanish. * Energetic, flexible and dynamic, operates with a high sense of urgency. * Quick learner & Excellent attention to detail. * 25 Years Experience in Medical Devices (Dental Industry). * 25 Years Experience in Medical Devices Under FDA Regulations, (Dental Industry). * Satisfactory written and verbal communication skills. * Excellent interpersonal, time man...

Tags for this Online Resume: Blue Prints, Blueprints, Calipers, CNC, Micrometers, Attention to Detail, Troubleshooting, Bilingual, Coaching, Communication Skills, manufacturing, production, "project management", machine operator

Featured Profile

Director of Quality & Regulatory- 22 Years of Experience - Near 45142

Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...

Ideal Companies: A company with suability, growth and development of their employees.

Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory

Chief Executive Officer - 20 Years of Experience - Near 33410

Career Highlights I have Intellectual Property in collaboration portals to enhance cross functional communication and organizational efficiency which has previously deployed across Health Care Providers (HCA), Healthcare Consultants (Studor Group), and Payers (BCBSVT). I successfully sold my software development and consultancy business and looking for new challenges. Entrepreneurial Leader with 3 Successful launches in the...

Tags for this Online Resume: Semiconductor Industry, Semiconductors, Start up, MicroElectronics, Fab, Intel, IBM, Management, Manufacturing, Acquisitions, P&L, IPO, VC Private Equity, Global Network

Clinical Research - 12 Years of Experience - Near 07086

EXPERIENCE Summary Write and review protocols that are in-line with the indication strategy. Conduct medical review and interpretation of efficacy and safety data from clinical trials. Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, review of Investigator Brochures, CTAs, Safety Data, Clinical Trial reports. Review and provide US feedback to protocols. Work with Clinica...

Tags for this Online Resume: Biopsy, Data Management, Management, Research, Chemotherapy, Clinical Research, Drafting, Process Improvement, Program Manager, Radiation

Lawyer

Solutions focused attorney specializing in regulatory and compliance law with experience in FDA and pharmaceutical related matters. Primary practice focuses on highly regulated matters including state pharmacy and controlled substance registrations drug distribution strategies mandatory reporting requirements and legal review for regulatory vendor contracts. Utilizes research experience and training to provide legal advice ...

Tags for this Online Resume: Distribution, Licensing, Policy Development, Family Law, Litigation, Management, Probate, Business Plan, Pharmaceutical

Pharmaceutical Sales Representative - 6 Years of Experience - Near 80230

Assisted Combined exceptional market cognizance with a practiced business sense developing and providing highly effective sales development leadership selling a range of pharmaceutical products and therapies to targeted prospects as well as an existing client base. Provided a high level of expertise for all aspects of market penetration initiatives. Developed customized sales presentations that maintain compliance with FDA ...

Tags for this Online Resume: Home Care, Neurological, Pharmaceutical, Communication Devices, Pathology, Therapy, Assessments, account executive, outside sales, sales representative, business development, inside sales

Programmer Analyst - 20 Years of Experience - Near 80112

Summary of Experience Senior SAS Consultant with experience in both UNIX and IBM Mainframe. Experienced in ETL (Extract Transform and Load), SDLC (System Development Life Cycle), RDBMS (Relational Data Base Management Systems) and SQL, as well as documentation and implementation of business functional requirements and technical specifications. Used various SAS software utilities like SAS/Connect and SAS/Access to extract da...

Tags for this Online Resume: Sun Solaris Operating System, Automation, Perl Programming Language, Support, System Analyst, Technical Support, Ad hoc reporting, ETL, Fileaid, Sync Sort, SAS

Quality Engineer - 20 Years of Experience - Near 00704

Possess over twenty (20) years of experience in the pharmaceutical, medical devices, biotechnology and manufacturing industries. Directly involved with Manufacturing Projects. Expertise in Investigations associated to process improvements. Experience in CAPA Investigation, Change Control, and other quality systems. Possess strong expertise from Analytical Laboratory Environment. Strong experience and expertise working in t...

Tags for this Online Resume: Budgeting, Client/Server, Control Systems, Cost Control, Data Management, HVAC, Information Technology, Infrastructure, IT Management, Local Area Network, manufacturing, "project management", Quality Systems, CSV Methodology, PLC/HMI, CAPA, Risk Management, Laboratory Software's Val., LIMS, FDA Regulations / Inspections