CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "cfr"

Safety and Health Professional

Professional Summary Versatile skill set with experience in Environmental Health and Safety, Emergency Medical Services, and Business Management. Practical knowledge of OSHA, EPA, ANSI, NFPA, ADEM and ISO 14001 regulations. Member of American Society of Safety Engineers. Presidential Member of Sigma Alpha Pi - National Society of Leadership and Success. Working knowledge of OSHA 29 CFR 1910, DHS 6 CFR 27, Safety Data Sheets...

Tags for this Online Resume: Advertising, First Aid, Cardiopulmonary resuscitation (CPR), Management, HR, Human Resources, Business Development, Inventory, Inventory management, Sales, Safety and Health

Clinical Pharmacovigilance/Drug Safety - 10 Years of Experience - Near 19440

Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...

Tags for this Online Resume: Protocol, Oncology, Audit, Monitoring, Critical Care - Neurology, ICH, Neurology, Quality Assurance, Test, Data Quality

Biological Technician - 3 Years of Experience - Near 94303

Summary: Experienced commissioning engineer with over 12 years of practical experience in biotech. Proficient with most equipment related to cell culture fermentation, and oral solid dose pharmaceutical manufacturing facilities. Very strong in GMP documentation FDA, ISO 9000, cGMP, CFR title 21 and DEA regulatory compliance. Familiar with LIMS, BMS, Trackwise, Faciliworks, Word, and Excel.

Tags for this Online Resume: Documentation, Automation, Honeywell, Schematics, Pharmaceutical, Science, BMS, Compliance, Good Manufacturing Practices, ISO, Validation

Quality Supervisor - 18 Years of Experience - Near 11434

SUMMARY A professional Quality Control and Quality Assurance Engineer/Specialist with 9 years of experience implementing and improving quality management systems/ programs to support Manufacturing, instrumentation, Validation, and processes Quality Management Systems and Information Management Systems Qualification Summary: Quality Assurance (manufacturing) * Experienced in ISO 9001 and ISO 13485 standards to ensure that pr...

Tags for this Online Resume: Quality Assurance, Test, Database, ISO, Management, Manufacturing, Procurement, Quality, Quality Control, Quality Management, manufacturing, production

Quality Assurance Director - 20 Years of Experience - Near 33545

BSI ISO 13485:2003 Lead Auditor (TPECS) Certification - Certificate: 7930649-76913 * Hired and entrusted by B Braun McGaw of Puerto Rico and LeMaitre Vascular to implement a wide-array of corrective actions and systems resulting from 3 FDA warning letters. Subsequently after new systems implementation received 0 FDA 483 observations for a combined period of 12 years. * Built company-wide shared quality visions which complet...

Tags for this Online Resume: Documentation, Quality Assurance, Compliance, Pharmaceutical Industry, Quality, Quality Control, Regulatory Affairs, Medical Devices, Pharmaceuticals, Regulatory Compliance

Motor Vehicle Inspector - 20 Years of Experience - Near 44278

Versed in Motor Carrier Compliance. Interact with Carriers, Shippers, Drivers, and all staff levels. Provide officials with interpretation of CFR49 Regulations in regard to their type of operation. Investigated Motor Carrier Complaints. Provide clients with regulatory awareness in the New Entrant phase of operation and provide appropriate transportation education. Speaker participant in transportation meetings and events. C...

Tags for this Online Resume: Distribution, MCS, Applications, Audit, Compliance, Microsoft, Microsoft Excel, Microsoft Word, Software, Training, transportation, Motor Carrier Safety Compliance, Motor Carrier Compliance Consulting

Technical Writer, Philadelphia metro, NYC, Connecticut, New Jersey

I am equipped with 25+ years of experience in Documentation Design/Development and Technical Writing. I am currently exploring gainful opportunity prospects in Pharma and Bio Research. * Analytical and detail-oriented Technical Writer, with vast experience in technical documentation development across various industries. Strong background in writing with superb written communication skills. Expert knowledge in document life...

Tags for this Online Resume: Documentation, Manufacturing, Validation, Technical Writer, Microsoft Excell, Change Control, Microsoft Office, Microsoft Visio Professional, Microsoft Word, GMP

General - 7 Years of Experience

KEY QUALIFICATIONS: * COMPLAINTS & TECHNICAL SUPPORT SPECIALIST WITH 5+ YEARS OF PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRY experience * 5+ years of experience with product complaints including experience with Global Customer Complaints (GCC), adverse events, and auditing of complaint records * Excellent knowledge of quality standards and regulations: FDA QSR 21 CFR 803 & 820, ISO Standards 9001 / 13485 / 14971, MDD 93/42/E...

Tags for this Online Resume: Complaints, Good Clinical Practices, Medical, Pharmaceutical, Support, Technical Support, Clinical Research, Project Management, Project Manager, Research

Project Manager - 20 Years of Experience - Near 91302

SUMMARY OF QUALIFICATIONS Accomplished IT Sr. Project Manager and Product Manager with a broad background, over 20 years of experience in all phases of SDLC including the areas of Application Development, Implementation, Deployment, Project Management, Process Improvement, Computer System Validation and other positions of increasing technical responsibility. Knowledge of regulatory requirements and cGMP for computer systems...

Tags for this Online Resume: Database, Database Design, Integrate, Business Requirements, Javascript, BASIC Programming Language, FACETS, Hospital Information Systems, HyperText Markup Language, Legacy, Project Management, Agile, Scrum Master

Operations Manager - 12 Years of Experience - Near 02360

My Professional objective is to join an organization in a challenging leadership role, allowing me to leverage my extensive management experience, creative problem solving and lean management skills with a growing company to achieve optimum utilization of its resources and maximize profits. 08/2011 - Present: Northeast Region Distribution Manager / Radiation Safety Officer * Responsible for thirty union staff and three non ...

Tags for this Online Resume: manufacturing, "project management", production, reliability

Quality Engineer - 10 Years of Experience - Near 63136

CAREER SUMMARY: Quality Specialist Professional with strong analytical skills in various lab settings such as environmental, animal, clinical and pharmaceutical. Experienced in research, laboratory, QA/QC, auditing, Quality measurement systems and technical writing. Familiar with GMP/GLP regulations in cGMP/cGLP manufacturing environment, EPA, FDA and CFR guidelines. Comfortable working in fast paced, priority shifting and ...

Tags for this Online Resume: Compliance, ISO, ISO 9000, Occupational Safety and Health Act, OSHA, Protocol, Research, Good Manufacturing Practices, Management, Research and Development

Airfield Operations Specialist - 10 Years of Experience

Summary: Special Skills Aviation Technician: * Fully trained and competent in blueprint/schematic reading and interpreting manufacturers' and customers' maintenance manuals, service bulletins, technical data, engineering data, and other specifications to determine feasibility and method of repairing or replacing malfunctioning or damaged components. * Contacting, establishing, and maintaining liaison with aerospace and equi...

Tags for this Online Resume: Carpenter, Management, Schematics, Spring, Support, Engineering, Government, Progress, Documentation, Extensible Markup Language (XML)