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Online Resumes with "FDA"
Engineer - 20 Years of Experience - Near 02720
Tags for this Online Resume: CAPA, process validation, process development, root cause investigation, ISO 13485, QSR / FDA CFR Part 820
Purchasing
AREAS OF EXPERTISE MRP, SAP, QAD, GP & Material Process Flow * Inventory Management * Supply Chain Management Contract Negotiations * Data Research & Analysis for NPI * Project Management * Strategic Sourcing FDA / International Regulations * Supplier Quality Assurance * Production Planning/Scheduling
Tags for this Online Resume: Purchasing, MRP, Scheduling, Forecast, Pricing, Process Improvements, Documentation, Production Control, QAD, Capital Equipment
Developer - 7 Years of Experience
PROFESSIONAL SUMMARY * Over 9 years of Clinical SAS programming experience in a Pharmaceutical industry involving different Phases (I, II & III) of clinical trials. * Experienced in working closely with statisticians to provide SAS programming in analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings, Summaries and Graphs/Figures (TLFs) for the Integrated Summary of Safety (ISS) and Integ...
Tags for this Online Resume: Microsoft Windows, SAS, Structured Query Language, Unix, Microsoft Windows 7, Windows 7, PDF, Proc, Extensible Markup Language (XML), Microsoft Excel
Quality Assurance Director - 4 Years of Experience - Near 08736
Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...
Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate
Operations Manager
AREAS OF EXPERTISE Finance & Accounting Budgeting Internal Control Profit & Loss Negotiations Process Development & Improvement Change Management Revenue Growth ISO, FDA & GMP Joint Ventures OSHA Risk management Supply Chain Information Technology Strategic Planning Lean Manufacturing QA & Testing Business Development Project Management Problem Solving
Tags for this Online Resume: Budgeting, Management, Manufacturing, Operating Budget, Quality, Quality Assurance, Quality Control, Accounting, Budgetary, Business Development
Director of Quality - 20 Years of Experience - Near 08810
Summary: Engineering professional with over 30 years of experience in developing, implementing, and managing Quality and Manufacturing management systems. Management experience includes working in small companies to global leaders in metal and plastic industries in diverse manufacturing environments. Working knowledge of ISO 9001, QS 9000, SQF, HACCP, cGMP, FDA (2ICFRPart 110,111,210,211), APQP (Advanced Product Quality Pla...
Tags for this Online Resume: ISO, Manufacturing, Process Control, Quality, Quality Assurance, Audit, Internal audit, ISO 9001, Management, Plastics, SQF, Food Safety, Risk Management, Quality System Implementation, Metal Fabrication, ANSI, ASTM and Mil Standards, FDA, 21 CFR 110,210,210,211, manufacturing, "project management", reliability, production
Quality Engineer
Summary: John has been an ASQ-certified Quality Engineer and ASQ-certified Quality Auditor and a Philips-Global-certified Lead Auditor with a strong experience within medical device, pharmaceutical and contract packaging companies, while following FDA drug Good Manufacturing Practices, FDA medical device Quality System Regulation, ISO 9001 and ISO 13485 environments. He has a solid understanding with QSR supplier control sy...
Tags for this Online Resume: Compliance, Quality Assurance, Support, Technical Support, Test, Corrective Actions, Medical, Medical Devices, ISO, Audit
Health Technologist
SUMMARY Analytical Chemist with expertise in quality control, stability studies, research and development, and manufacturing. Exceptional ability to work independently and as a team member. Skills include: * Subject Matter Expert on NMR (Bruker Avance 400 MHz) Trained five QC analysts on methodology of NMR assays and revised SOP for NMR assay * Performed troubleshooting for instrument operations, test results, and project i...
Tags for this Online Resume: Pharmaceutical Industry, Quality, Quality Assurance, Quality Control, Test, High Performance Liquid Chromatography (HPLC), Spectrophotometer, Instrumentation, Manufacturing, Research
Department Manager
PROFESSIONAL SUMMARY I am a highly efficient, dedicated and industrious individual. Maintenance Manager/Plant Manager/Distribution Manager with over 20+ years' experience in addition to strong interpersonal, training and communication skills. I am a proactive achiever with a passion to deliver outstanding results using a well-versed, practical, hands-on background in Maintenance Management. I have managed the maintenance an...
Tags for this Online Resume: Inventory, Training, Preventive Maintenance, Procurement, Quality, Services, Manufacturing, HP, Install, Capital Expenditures
Surgical Technologist - 8 Years of Experience - Near 85225
SUMMARY OF QUALIFICATIONS Nationally Certified Surgical Technologist 10 years of experience as surgical technologist The first Surgical Technologist in the Nation to assist with adipose tissue derived stem cell harvesting and transfer Assisting surgeon in Phase I FDA trial on adipose tissue derived stem cell Traveled to other countries to assist surgeon in training other physicians In depth knowledge of diagnosis treatment ...
Tags for this Online Resume: Operating Room, Surgery, Surgical, VITAL SIGNS, Communication Skills, Orthopedic, Orthopedics, Plastic Surgery, Skill, Training, Stem Cells, Dedicated
Production Manager
Additional Qualifications * Experienced with the following software and systems: MS Office, SAP, Trackwise, Minitab, etc. * Experienced in technical writings such as Work Instructions, SOP's, PPM's, Capital Expenditure Requests, Preventive Maintenance Techniques, Single Point Lessons, Validation Protocols, Demand Flow Technology, etc. Experienced with the following regulations and standards: FDA, GMP, HACCP, ISO 9001, ISO 1...
Tags for this Online Resume: Consulting, Scheduling, 5S, Business Management, Facilitator, Inventory, Management, Process Improvements, Diagnostics, Operational Excellence
Chemist - 15 Years of Experience - Near 44131
Summary of Qualifications Motivated, talented and disciplined Quality Manager with wide-ranging experience leading laboratories and cross-functional project teams. Extensive technical experience with good working knowledge of online services. Adept at learning and applying new concepts. * Project Management * Staff Management * Stability Guidelines * Strategic Planning * Final Product Testing * Chemical Processes * Budgetar...
Tags for this Online Resume: Compliance, Chemistry, Quality, Quality Assurance, Quality Control, Management, Problem Solving, Product Development, Project Management, Services
