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Online Resumes with "fda regulations"
In Between - 5 Years of Experience - Near 500081
Career Summary * SAS Certified Base for SAS9 with more than four years of experience. * Worked on different Phases of clinical trials and I have experience in programming, SDTM, ADAM and reporting in Clinical Research using SAS environments. As a Clinical SAS * Worked on Various Complicated SDTM domains like LB, MO & OE for ophthalmoscopy studies * Understanding of the study Documents and Data (e.g. Study design and objecti...
Tags for this Online Resume: A SERIES, Active Directory Application Mode (ADAM), Base SAS, Cardiology, Clinical Research, Data Management, Documentation, Generate Reports, HyperText Markup Language, Macro (Predefined Code)
Engineering Technician
Qualifications: Mr. Stafford has acquired several years of experience in a vast array of electronic, electrical, chemical and mechanical disciplines. His experience includes, but is not limited to: Quality Inspector, Weld Inspector, Electronics Technician, Electronic Counter Measures Technician, Supervisor, Site Supervisor, Human Engineering, Application Engineering, and Information Management Officer. A Wisconsin State lic...
Tags for this Online Resume: Engineering, Amazon Web Services, Amplifier, Cabling, Cardiopulmonary resuscitation (CPR), Computer Operations, Control Systems, Corrective Actions, Distribution, Electronic Warfare
Clinical Research - 0 Years of Experience
Good expertise in clinical trials and GCP ICH and FDA regulations * Ability to anticipate problems relating to projects and to develop and implement solutions Skilled with PC applications Microsoft Office Excel Outlook Oracle including patient and study databases and spreadsheets * Manage multiple projects at varying stages of completion * Effective in setting and meeting personal short- and long-term goals to complete assi...
Tags for this Online Resume: Data Analysis, ADA, Ada Programming Language, Audit, Inventory, Medical, Medical Records, Oncology, Oracle, Pathology, clinical, phase i, phase ii, clinical trials, phase iii, cro, pharmaceutical, regulatory, research
Scientist - 15 Years of Experience - Near 10954
SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...
Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, Filing, regulatory
Medical & Clinical Laboratory Technician
Summary of Qualifications: Growth-minded operational professional with a collaborative and innovative approach to problem solving. A proven ability to implement and execute project timelines, objectives, management and oversight of early phase global studies. Exceptional communication and relationship building skills allow continuous success with cross-functional, internal and external partnerships and stakeholders. * Diver...
Tags for this Online Resume: Management, Monitoring, Oncology, Protocol, Quality, Quality Assurance, Assessments, Filing, Financial, Planning
Manager
PROFESSIONAL SUMMARY I am seeking an IT leadership position. I have excellent team building skills and strong technical skills. I have consulted for large organizations including Google, Visa, Robert Half International, San Jose Water, Oracle, Sun, Sega, San Jose State University as well as dozens of startups. I have been the project manager on numerous rollouts and technology migrations. I have the ability to explain techn...
Tags for this Online Resume: Wireless, Structured Query Language, Accounting, e-Commerce, Manufacturing, NOC, Retail, SAP, Software, Software Development
Chief Operations Officer
SUMMARY OF QUALIFICATIONS Extremely dedicated and detail-oriented professional with an extensive record of improving operations in the trucking industry to achieve unprecedented cost-efficiency utilizing proven expertise in the following areas: Areas of Expertise * Cargo Loss Prevention * Cargo Theft Prevention * Crisis Management * Risk Management * Team Building & Training * DOT Compliance * OSHA Compliance * Safety Compl...
Ideal Companies: Consultant
Tags for this Online Resume: Compensation, Distribution, Occupational Safety and Health Act, OSHA, Compliance, Safety Equipment, Training, Security, Microsoft Internet Explorer, Pharmaceutical Industry
Quality Manager - 16 Years of Experience - Near 07114
PROFILE Compile an outstanding record of success and significant contributions in the field of QA/QC. Develop an in-depth understanding of pharmaceutical documentation and quality system, been a top performer in high-pressure situations and an excellent problem solver. Have the ability to work well in a project team environment, leader and an asset to any organization. STRENGHTS Complete familiarity with FDA regulations, US...
Tags for this Online Resume: Purchasing, Quality Assurance, Test, Complaints, Documentation, Management, Oracle, Packaging, Regulatory Affairs, Trend Analysis
Scientist - 15 Years of Experience - Near 10954
SUMMARY: * A pharmaceutical scientist with more than 15 years of experience supporting product development activities in an FDA regulated environment. * Seeking a position where my knowledge and skills in Pharmaceutical Product Development and CMC documentation can be applied with a potential for professional growth. * Skilled in the application of various physico-chemical analytical techniques in raw material and finished ...
Tags for this Online Resume: Enterprise Requirements Planning, Information Requests, Oracle, Oracle ERP, DSC, Product Development, Research, SAP, C Programming Language, Filing
Principal Engineer
ACCOMPLISHMENTS * Project management of Medical Device right from conceptualisation to manufacture in an ISO/FDA regulated environment. Used suitable stage gates and milestone list to inform key stakeholders about progress of the project. * Planned the project budget, schedule and used change control procedures for controlling changes and preventing scope creep. Negotiated with functional managers for resource allocation an...
Tags for this Online Resume: Medical, Medical Devices, Engineering, Instrumentation, ISO, Management, Cancer, Documentation, Manufacturing, NPI
President - 0 Years of Experience - Near 21804
SUMMARY OF QUALIFICATIONS Extremely dedicated and detail-oriented professional with an extensive record of improving operations in the trucking industry to achieve unprecedented cost-efficiency utilizing proven expertise in the following areas: Areas of Expertise * Cargo Loss Prevention * Cargo Theft Prevention * Crisis Management * Risk Management * Team Building & Training * DOT Compliance * OSHA Compliance * Safety Compl...
Tags for this Online Resume: Compensation, Distribution, Occupational Safety and Health Act, OSHA, Compliance, Safety Equipment, Training, Security, Microsoft Internet Explorer, Pharmaceutical Industry, management, manager, Consultant, Transporation Managment, Violation, Logistics Managment, Quality Assurance, Transportation Consultant, Violation Consultant, Quality Assurance Consultant, Logistics Consultant
Director of Quality - 24 Years of Experience - Near 11801
Professional Summary Highly effective professional offering 30 years of US global quality leadership experience developing strategies, improvement action plan and solutions. Dedicated leader to bring organizations together, focusing on hi performance culture leading to improvement and efficiency. Built fully engaged team that is motivated to achieve metrics and deliver ROI. Lead and empowered cross functional teams to impro...
Ideal Companies: end of the year 449.00 + 4 months of our service. resume rewtire and cover letter.
Tags for this Online Resume: TQM (Total Quality Management), Manufacturing, Assessments, Audit, Quality, Quality Management System, HACCP, Continuous Improvement, PCQI, Supplier site and internal audits, USDA, FDA, ISO 9001, SQF, BRC, ISO 22000, ERP, OOS, Investigation, CAPA, NCR