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Online Resumes with "FDA "



Clinical Quality Assurance - 20 Years of Experience - Near 46360

Managed Quality Control / Quality Assurance / Regulatory Affairs departments in different roles for different companies for manufacturing packaging and distribution of drugs and devices. Designed flow processes for improvement of quality of products and quality of documents using proper validation protocols and procedures. Built quality management systems three times upgrading: Customer complaints investigations document co...

Tags for this Online Resume: Quality Assurance, Test, HYGIENE, Management, Publications, Quality, Six Sigma Quality, Packaging, Corrective Actions, Instrument Calibration, protocol, pharmaceutical, preventive maintenance

General - 10 Years of Experience - Near 07057

Professional Summary 20+ years as an administrative professional / executive partner, currently as a Service Coordinator at Integrated Security. Praised by executives and colleagues for exceptional skill in anticipating needs and implementing solutions before requests are made. Recognized for being customer focused and a team player to ensure efficient department workflow. Selected by company leaders to develop and implemen...

Tags for this Online Resume: Support, Human Resources, Benefits, Billing, Communication Skills, Customer Service, Data Entry, Distribution, Documentation, Government, human resources, hr, customer service, honeywell, ProWatch, service coordinator

Purchasing Agent - 20 Years of Experience - Near 14626

PROFESSIONAL SUMMARY Over twenty years of self -motivated and hands-on experience in a broad range of commodities and services on a global basis in many industrial manufacturing environments including strategic sourcing, purchasing, contract negotiation and management, and Supply-Chain management. Extensive experiences are in project management, strategic planning, lean process and execution, cost analysis and contract nego...

Tags for this Online Resume: Electronics, Government, Inventory, Inventory Control, Laptop Computer, Logistics, Marketing Management, Purchasing, UL, Automotive

Process Engineer - 15 Years of Experience - Near 55376

To benefit an organization that can use a knowledgeable Six-Sigma Black Belt Quality Manager with a proven ability to continuously improve processes/customer satisfaction and supplier development while building a strong project team, and strengthen customer relation using various Six-Sigma/Project Management tools and methodologies. Responsibilities: ISO 13485, 14971 Managing/Directing quality staff. Supervising/ Mentoring ...

Tags for this Online Resume: Audit, Data Analysis, CMM (Capability Maturity Model), Management, Product Development, Reliability, Stents, Heat Treating, Plastics, Msa (Accounting Pkg)

Engineering Manager - 20 Years of Experience - Near 76049

Summary * Engineer, Project Manager and Mentor with Executive Management Experience * Effective communicator and author experienced in bridging diverse audiences * Skilled in CRM, NPI, PLM, DFM, DFT including FCC / UL / CE / FDA certifications * Diverse Electro-Mechanical skills: RF, Analog, Embedded, IOT and Mechanical Design * Strong in Root Cause Analysis, Cost Control Management, Quality Improvement

Tags for this Online Resume: Manufacturing, Legacy, Cost Control, Engineering, Gateway, ISO, ISO 9001, Management, Project Management, Distribution, project engineer, project manager

Quality Assurance Specialist - 7 Years of Experience - Near 75093

Professional SUMMARY * Over all 7 years of experience in the IT industry in Quality Assurance using Web based and Client/Server applications. * Knowledge of Healthcare, Pharma, Security and Biometric projects. * Key expertise includes testing Extensive experience in Manual and Automated testing using Selenium and defect tracking tools like HP Quality Center (ALM/QC), Bugzilla, JIRA and Bug Zero. * Conversant with all phases...

Tags for this Online Resume: Management, Oracle, Regression Testing, System Testing, Test, Software, JIRA, Microsoft, Microsoft ASP.Net, Microsoft SQL Server

Engineering Manager - 20 Years of Experience - Near 33027

SUMMARY OF QUALIFICATIONS Committed professional with twenty two years of demonstrate experience in Maintenance and Project Management for pharmaceutical, private industries and federal government. Special attention to: facilities, utilities, projects, maintenance, manufacturing and administration. Dynamic, confident, quality and service oriented, self motivated leader and team contributor. Successful development and execut...

Tags for this Online Resume: Integrate, Procurement, SAP MM module, Coaching, Government, Instrumentation, Pharmaceutical, Pharmaceutical Industry, PMP, Project Management

Life Scientist - 20 Years of Experience - Near 20721

Summary * Project Officer and Work Assignment Manager human health toxicologist in the in the U.S. Environmental Protection Agency's (USEPA) Office of Water (OW) to support agency products registration and other regulatory activities * Developed human health benchmarks for registration/regulation of drinking water and environmental contaminants for the USEPA * Developed multivariate computational toxicology in silico QSAR m...

Tags for this Online Resume: Risk Assessment, Management, Toxicology, Integrate, biologist, toxicologists, Assessments, Cancer, Data Analysis, Database, ESA

Clinical Quality Assurance - 20 Years of Experience - Near 19021

SUMMARY OF QUALIFICATIONS: Capable and accomplishment driven individual, with over 20 years of experience in the Pharmaceutical / Drug Development Industry. A flexible problem solver with excellent written and interpersonal communication skills and a dependable team member at both associate and management levels with recognized achievements in the following areas: * Operational experience and management in Primary and Secon...

Tags for this Online Resume: Compliance, Packaging, SharePoint, Sharepoint Technologies, Data Entry, Management, Project Management, Capital Assets, Assessments, Audit, physical therapist, pharmaceutical, trial, clinical

Not Listed - 17 Years of Experience - Near 53562

Areas of Expertise * Quality Engineer * Non-Conformance * Auditing * Product Surveillance * Training & Staff Development * Medical Device & Pharma * Complaint Review * Policy & Procedures * FDA/MDR Reporting * Subject Matter Expert * Complaint Investigation * 21CFR Part 210 and 211 * 21CFR Part 820 and 803 * ISO 9001, 13485 & 14001 * Laboratory Testing * Calibration and Validation * Federal Compliance * International Compli...

Tags for this Online Resume: Quality, Quality Assurance, Systems Operations, Documentation, Instrument Calibration, Notebook Computer, Project Coordinator, Process Improvement, Typing, Inventory, human resources

Production Supervisor - 9 Years of Experience - Near 98115

PROFILE Management professional with extensive experience in guidance of high quality manufacturing. Proven ability to promote productive collaboration within and outside of corporation. Responsible for high volume production and packaging of components for internationally marketed, FDA licensed, diagnostic kits. Avid and capable manager of schedules and projects.

Tags for this Online Resume: Seattle, Biology, Production Supervision, ERP experienced, Management, Western blot, Chemistry, ELISA, Immunology, Research, manufacturing, production, reliability, maintenance

Production Manager - 20 Years of Experience - Near 01702

Summary Manufacturing Professional - Solid experience directing and supporting multi-shift, cGMP/QSR production operations for medical device product lines in an FDA registered facility. Managed team of 60 employees and 3 supervisors. Responsible for compliance with FDA 21 CFR Part 820 and ISO13485 regulations. Character - a strong work ethic of integrity and honesty with perfect attendance Additional Qualifications High pu...

Tags for this Online Resume: Lean Manufacturing, Manufacturing, Packaging, Disaster Recovery, Inventory, Sales, Allergy, Pharmaceutical, Purchasing, Quality Assurance, manufacturing