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Online Resumes with "fda "



Quality Assurance Specialist - 20 Years of Experience - Near 80421

Areas of Expertise FDA ISO / IEC Quality Systems Risk Management FMEA V&V Testing Web Application Testing HLM / Quality Center SDLC Qualification Protocols Agile RoHS Compliance

Tags for this Online Resume: Documentation, 21 CFR Part 11, Quality Center, Quality Assurance, Testing, ISO, Validation, Agile, Audit, Compliance, IEC, JIRA, FDA, Software, IQ, OQ, PQ, Medical, FMEA, Functional, Acceptance, Performance, Verification

Project Manager - Near 19064

SUMMARY OF QUALIFICATIONS A career naval officer possessing a broad range of Microsoft Office, complex project management, technical writing and illustration skills, I have performed as an Agile IT project manager, FDA validation specialist, forensic auditor, business process analyst and PMO team technical documenter. As such I have led, researched, analyzed, tracked and documented critical audits, IT projects and startups ...

Tags for this Online Resume: Project, Manager, Technical, Writer, Business, Systems, Analyst, Solutioner, Aerospace, Automotive

Quality Manager - 11 Years of Experience - Near 07077

Areas of expertise: Product Development - Outside Sourcing - Vendor Relation Interaction - Suppliers Interactions - Management - Personal Development Growth of Team Members- Quality Systems Consultation - Strategic Planning - Deviation Investigation - FDA Compliance - Root Cause Analysis - Budgeting Needs Assessment - Customer Service - Process Improvement & Optimization -Quality Assurance -Project Management - Audits Produ...

Tags for this Online Resume: Packaging, Quality, Forklift, OSHA, Toxicology, Management, Audit, Compliance, Computer Aided Software Engineering, Documentation

Plant Manager

PROFESSIONAL SUMMARY Management Professional with experience in, Manufacturing Management, Quality Management, Product Development, Sales, and Business Management. Successes in cost reduction and increased productivity while concurrently improving organizational quality and customer service. Over 25 years Manufacturing Operations Management experience. Adept in both union and non union relationships, team building, problem ...

Tags for this Online Resume: Safety, HACCP,FDA, and SQF, Manufacturing, Quality, Quality Assurance, Capital Planning, P&L Responsibility, Distribution, Packaging

Quality Engineer

Professional Summary * An resourceful Supplier Quality Engineer with Process Engineering experience in a wide variety of Manufacturing methodologies and demonstrated experience in the following: Rotational / Prismatic Manufacturing/ Plastic Molding Sheet Metal / Punch Press New Product Development Supplier Quality Assessment / Design For Manufacturability Geometric Dimensioning / Tolerancing Statistical Process Control / Si...

Tags for this Online Resume: Assessments, Quality, Applications, Complaints, Data Analysis, Diagnostics, Engineering, Green Belt, Integrate, ISO

Production Manager - 20 Years of Experience - Near 00907

SUMMARY Consulting experience. Strong knowledge in product transfer, packaging engineering, FDA, European and Japan regulations, and Quality Systems. Excellent project management skills. Experienced in vendor management and corporate supplier certification programs. Engineering Educational experience and Train the trainers. ISTA Certified. ASQ Certified Six Sigma Black Belt. Member of Parenteral Drug Association (PDA).

Tags for this Online Resume: Database, Engineering, Health Care Industry, Industrial Engineering, Management, Manufacturing, Manufacturing Engineering, Material Management, Supply Chain, Professional Services

Clinical Research - 7 Years of Experience - Near 77449

Experienced professional seeking to fill a challenging career with a company willing to utilize my clinical, medical, and management skills.

Tags for this Online Resume: Research Manager, Good Clinical Practice GCP, Clinical Research Coordinator, IRB, Clinical Trials, FDA Regulations, Patient Care, Protocol, Assessments, Clinical Research

Production Inspector

Professional Summary Skills Team leadership, supervisory Quality control, auditor, Kanban s k ills inventory, cycle counting, clean room, line clearance, food industry production, pharmaceutical packaging, data entry, documentation Automotive production/assembly cGMPs, cSOPs, familiarity with operations, plastic injection mold, OSHA, FDA, ISO quality standards, hard-coating lens, metalizing 5s. safety components, ability to...

Tags for this Online Resume: Clean Room, 5S, Automotive, Billing, Communication Skills, Data Entry, Distribution, Documentation, Inventory, ISO, Team Lead, Quality Control, GMP, FDA, OSHA, CHARLOTTE, NC, Customer Service

Construction manager

Summary of Key Projects: * Flying Food Group, JFK Airport, New York: Managed onsite operations in New York for this one year, $7.3 million project to renovate 160,000 sq. ft. existing food processing facility meeting current FDA and USDA requirements worked closely with Port Authority of New York and New Jersey during permitting processes, as well as EPA and other government organizations to remove existing toxic contaminat...

Tags for this Online Resume: Food Service, Budgeting, Schematics, Services, Utilities, Architectural, Build Management, Management, Planning, Project Management, Industrial / Manufacturing

Life Scientist - 8 Years of Experience - Near 27617

Summary Ph.D in Pharmaceutics with extensive experience in analytical method development, method transfer and validation for Small and Large molecular API, in a GMP environment. Specialized in mass spectrometry/LC-MS method development and troubleshooting. Good knowledge of the GMP, GLP, SOP practices, the USP, EP, NF, FDA and ICH guidelines. Proven problem solver, motivated team leader and excellent communicator Qualificat...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics

Production Manager - 10 Years of Experience - Near 92656

Career Summary: * Working knowledge of FDA regulations, ISO standards, with the understanding of engineering disciplines and manufacturing. * Specializing in company Quality Management Systems (QMS). Revising the current document management systems and setting up new company wide Document Control Systems from the ground floor and up. * Design Mechanical, Electrical, Printed Circuit Boards and cables. With the ability to und...

Tags for this Online Resume: Quality, Document Control, Engineering, Management, Product Development, Support, Autocad, Autodesk AutoCAD, Baan, CAT