CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "21CFR"

Project Manager - 20 Years of Experience - Near 30655

HIGHLIGHTS OF QUALIFICATIONS * Providing Key Project Management (PMP) as well as hands on experience in the Acquisitions and Mergers of business technology and business practices into new business platforms. This would be the integrating old business legacy systems with new technology or integration into new owner systems and software. Mergers with Airline, Banking and Automotive companies. * Senior management consultant wi...

Tags for this Online Resume: Security, Cellular, Software, Software Development, Strategic Initiatives, ACD, Vignette, Adobe, Automatic Call Distribution, e-Commerce, it jobs, agile, software, sql, Senior Program / Project Manager, M&A Consultant

Quality Engineer - 15 Years of Experience - Near 10312

Summary of Qualifications * Provide validation services for pharmaceutical clients to be compliant with FDA regulations utilizing CSV methodology * Professional with a strong background in validation, quality, information technology, and chemistry domains for pharmaceutical and medical device industry * Proven knowledge of FDA regulatory requirements, including cGxP, GLP, GMP, Sarbanes-Oxley (SOX), 21 CFR 210/211, 21 CFR 58...

Tags for this Online Resume: Services, Data Migration, Legacy, Quality Assurance, Assessments, Audit, Management, Quality Management, Pharmaceutical, Quality, validation, CSV, business analyst

General - 16 Years of Experience - Near 06443

A multi-disciplined, results driven, and goal oriented quality management leader with over twenty years of experience in the regulated pharmaceutical industry. A diverse background that includes all aspects of Quality Assurance (QA) management, Information Technology (IT), and project management. A customer focused and self-motivated team player with a history of working as a leader in team-oriented environments. Success...

Tags for this Online Resume: Auditing, Computer Systems Validation, CAPA, Quality Systems, Research and Development, Pharmaceutical Biotech, Auditing, Quality Management, Computer Systems Validation, CAPA, Supervision, GMP, 21 CFR Part 11, Quality, Quality Assurance, Good Laboratory Practices, Software Quality Assurance, Software Validation

Clinical SAS Programming - 20 Years of Experience - Near 98368

I am a SAS programmer looking for a remote, work from home position I recently moved to a remote area of the Olympic peninsula in the state of Washington, 2 hours west of Seattle. I am looking for a remote, work from home position as a clinical trials SAS programmer. I have experience in applying software engineering and risked-based quality assurance principles to develop a lean, efficient, modular, and well tested ...

Tags for this Online Resume: SAS, 21 CFR Part 11, software engineering, SAS Macros, Statistics, Oncology, manager, CDISC

Director of Quality - 20 Years of Experience - Near 91325

Summary of Career Milestones: * BS degree in Industrial Technology. Final semester of a combined Masters Program * 25 years in various manufacturing environments including electro-mechanical, medical devices and Aerospace/Defense * Lean Six Sigma Master Black Belt Certified (LSSMBB) (Global Cert - Germany and Villanova University) * Multiple Quality related certifications from ASQ, ASNT, RAB, IRCA, SME. * Certified Internat...

Tags for this Online Resume: Test, Engineering, Reliability, Management, Manufacturing

Programmer Analyst - 8 Years of Experience - Near 22042

PROFESSIONAL SUMMARY * Over 8 years of experience in Information Technology field with strong emphasis in SAS Application Analyst/ Programmer with 3+ years of hands on experience and professional experience in Clinical Trial projects and also worked as Application Analyst in the CROs, Healthcare and Pharmaceutical industries. * Experience in analyzing and coordinating clinical data, generating detail summary reports and dat...

Tags for this Online Resume: Management, Oracle, Oracle 9i, Information Technology, Process Improvements, Coding, Health Care Industry, HyperText Markup Language, Manufacturing, sql, SAS analyst

Chemical Engineer

PROFILE project management and handling instruments/equipment * Good understanding of various chemical processes (Distillation, Heat Transfer, Fluid Mechanics, Chemical Reaction Kinetics) * Excellent knowledge in ISO Standards, FDA guidelines 21 CFR Part 11, Part 210, Part 211, SOP, cGMP, cGLP, Audit trails, GAP Analysis * Familiar with safety protocols followed in research labs and worked on projects/assignments related to...

Tags for this Online Resume: Statistical Analysis, Audit, Autocad, Autodesk AutoCAD, C Programming Language, CFR Part 11, Corrective Actions, Green Belt, HAZOP, HTTPs

Quality Assurance Specialist - 7 Years of Experience - Near 08844

Career Summary: Over 9+ years of extensive hands on experience "High potential Software Test Engineer" in diversified fields of the Software Development Life Cycle, specialized in, Quality Assurance Process, Test Automation, Software Testing, Verification, Validation and Reporting across multiple platforms. Seeking position as Validation / Quality Analyst to utilize my expertise and further knowledge. * Excellent experience...

Tags for this Online Resume: Acceptance Testing, Documentation, Pharmaceutical, Test, Test Cases, Test Plan, User Acceptance Testing, Applications, Java Programming Language, Web

Managing Director - 20 Years of Experience - Near 33076

PROFILE Results-driven Sr. Level Manufacturing & Supply Chain Manager known for directing operations for high tech products across multiple geographies. Expertise includes New Product Introduction, Supply Chain Operations, Procurement, Logistics, Production Scheduling, Manufacturing, Operations, Business Process Reengineering, Manufacturing Consolidation, Program/Project Management and Technological Initiatives. Recognized ...

Tags for this Online Resume: ISO 9001, Lean Manufacturing, Manufacturing, P&L, Payroll, Purchasing, Motorola, Inventory, management, manager, project manager, six sigma, managerial accounting, supply chain management, operations management, New Product Introduction, Contract manufacturing, High Tech, Planning

Biostatatician - 18 Years of Experience - Near 07059

Experienced with IND/NDA submissions, and knowledgeable in regulatory guidelines (ICH), 21 CFR Part11 and Good Clinical Practice (GCP). * Highly experienced in clinical protocol development, experimental design, sample-size and power calculation, randomization, and study analysis planning (SAP). * Proficient in SAS/Base, SAS/Stat, SAS/Graph, SAS/Macro and SAS/ODS. * Skillful in data validation data manipulation, graph, tabl...

Tags for this Online Resume: Health Care Industry, clinical, protocol, sas, pharmaceutical, sap, ich, gcp, trial, phase, oncology

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