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 ...
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Project, Manager, Technical, Writer, Business, Systems, Analyst, Solutioner, Aerospace, Automotive
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...
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Packaging, Quality, Forklift, OSHA, Toxicology, Management, Audit, Compliance, Computer Aided Software Engineering, Documentation
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 ...
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Safety, HACCP,FDA, and SQF, Manufacturing, Quality, Quality Assurance, Capital Planning, P&L Responsibility, Distribution, Packaging
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...
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Assessments, Quality, Applications, Complaints, Data Analysis, Diagnostics, Engineering, Green Belt, Integrate, ISO
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).
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Database, Engineering, Health Care Industry, Industrial Engineering, Management, Manufacturing, Manufacturing Engineering, Material Management, Supply Chain, Professional Services
Experienced professional seeking to fill a challenging career with a company willing to utilize my clinical, medical, and management skills.
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Research Manager, Good Clinical Practice GCP, Clinical Research Coordinator, IRB, Clinical Trials, FDA Regulations, Patient Care, Protocol, Assessments, Clinical Research
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...
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Clean Room, 5S, Automotive, Billing, Communication Skills, Data Entry, Distribution, Documentation, Inventory, ISO, Team Lead, Quality Control, GMP, FDA, OSHA, CHARLOTTE, NC, Customer Service
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...
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Food Service, Budgeting, Schematics, Services, Utilities, Architectural, Build Management, Management, Planning, Project Management, Industrial / Manufacturing
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...
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High Performance Liquid Chromatography (HPLC), ELISA, protein, Protocol, LC-MS, MASS, API, Process Improvement, Application Program Interface, FORMULATION, QC, ANALYTICAL, pharmaceutics
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...
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Quality, Document Control, Engineering, Management, Product Development, Support, Autocad, Autodesk AutoCAD, Baan, CAT
