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Online Resumes with " FDA"



Executive in the pharmaceutical and biotechnology areas

I am an executive with 25-years experience and a demonstrated success in pharmaceutical and biotechnology drug development, drug discovery and delivery of conventional drugs, proteins, and peptides; I am well-versed in regulatory requirements and interactions with the FDA and other regulatory agencies. As a PI on NIH funded projects, I conducted Phase 1 and Phase 2 clinical studies in mucositis, severe sepsis and nosocomial...

Tags for this Online Resume: program leader, project leader, consultant, preclinical, drug characterization, assay validation

Senior Buyer

Very experienced Senior Buyer, SAP expert for Materials, FDA regulations, On Time In Full metrics. Worked with Fortune 100 company for 23 years.

Tags for this Online Resume: SAP, Medical Device

Computer Tech

good organizer, resourceful, loyal

Ideal Companies: KC Life Company

Tags for this Online Resume: purchasing, troubleshooting

QA/RA Manager / Senior Quality Engineer

I am seeking a like position with both challenge and room for unique contributions my background and experience can bring. I am willing to relocate for the right opportunity.

Ideal Companies: New Start-ups

Tags for this Online Resume: Company-Wide Quality Systems design, development & Certification to FDA/QSR, ISO13485 and all other associated regulatory requirements in both domestic and international markets for a broad range of Class I, II & III Medical Devices, Documentation/Data Control Management – CFR21 Part 11 Compliant, Develop/Manage Contractor-Supplier-Customer Partnerships (Internal & External) for Custom & Off-the-Shelf materials and components fabrication, assembly, sterilization, packaging, storage & distribution from Domestic & Global resources, Strategic Planning for Products / Budgets & P/L Responsibility, Lead Auditor for External QS Audits / Develop & Manage Internal Audit Programs, Post Market Surveillance Management, including Customer Service & Compliant Handling, for Continuous Improvement Program

Shannon Cooley

Apply my background and experience in an FDA regulated industry.

Tags for this Online Resume: Pharmaceutical, Research & Development, Quality Audits, Manager, Chemist

Goal-oriented, meticulous, highly organized

not only exceptional technical competency but also superior analysis, problem-solving abilities, leadership, communication and team member experience.

Ideal Companies: Companies that have more than 50 employees and been in business for awhile.

Tags for this Online Resume: sales and marketing, customer service, regulatory affair, research and development, management, sales, development

experienced salesman

Dynamic leader and proven team player Exemplary interpersonal and communication skills, both verbal and written Exceptional problem solving proficiency – lateral thinking Ability to handle pressure effectively Strategic thinking, loyalty

Ideal Companies: PEPSICO, KRAFT, COCA-COLA

Tags for this Online Resume: sales, product manager, import specialist, quality assurance, account management

Senior Global Vice President of Clinical Development and Medical Affairs

To develop uniqie compunds and biologics to fill unmet medical needs.

Tags for this Online Resume: biologics, diabetes, endocrinology, metabolic diseases , medical writer , extensive FDA experience

Clinical supply coordinator

Senior scientist/clinical supply coordinator with broad experience managing and coordinating pharmaceutical clinical supply systems for API’s, Excipients, Packaging components, Finished drug products including Controlled substances, Reserve samples, and Chemical archives. Labeling and distribution of GMP Clinical supplies for worldwide GLP and GCP studies. Reconciliation and disposition of returned clinical supplies. Pro...

Tags for this Online Resume: Organization, Document control, Inventory management, Leadership, Proactive

import, customs, compliance, logistics, international, trade, broker, NAFTA, tariff, harmonized, Global Management, International Marketing, International Business Transactions and Transportation, US Laws, international laws, the European Union political

Logistics, import, or Custom Compliance position

Ideal Companies: Importers, International Trade

Tags for this Online Resume: Compliance and Training Coordinator diversified background with twelve (12) years experience. Additional experience includes but not limited to: Import, Logistics, Customs Compliance, Harmonized Tariff Schedule (HTSUS), international trade, GATT, WTO, WCO, Customs and Border Protection, FDA, USDA, and other government organizations. Expert recognized in customs compliance with a superior rapport with Customs and other government officials. Led and educated the import department operations. Created and advised import compliance procedures, and informed customers of compliance issues. Completed M.B.A. in Global Management while working full time. Via my educational goals I have obtained knowledge in: Global Management, International Marketing, International Business Transactions and Transportation, US Laws, international laws, the European Union political and legal environment, tariffs, duties, trade barriers, International markets. international logistics, ATA Carnet, collection documents, international consumer markets, industrial markets, pricing in international markets cultural differences, Multinational Markets, and, counter trade.

LPN

Motivated and client oriented.

Ideal Companies: Teletech, Verizon, Suddenlink

Tags for this Online Resume: customer service, LPN

Biotechnology QA Manager

Tags for this Online Resume: Compliance, Biotechnology, Quality Control, FDA, Bio Devices