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Were you looking for CFR-Part-11 job results?
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Online Resumes with "CFR Part 11"
Team Leader - 9 Years of Experience - Near 08854
Experience Summary * A seasoned analytics and consulting professional with ~9 years of industry experience as a SAS Consultant and Business Data Analyst with a strong understanding of Data Handling and Management, SAS, Project management, and Business Analysis. Project Summary This program supports the in-out of the company's innovative value-based programs. This includes the analyses of business KPIs and financial metrics ...
Tags for this Online Resume: Programming, Support, ETL, QA, Management, Data Extraction, Project Management, Requirements Analysis, SAS, Data Analyst
Quality Assurance Specialist - 20 Years of Experience - Near 80421
Areas of Expertise FDA ISO / IEC Quality Systems Risk Management FMEA V&V Testing Web Application Testing HLM / Quality Center SDLC Qualification Protocols Agile RoHS Compliance
Tags for this Online Resume: Documentation, 21 CFR Part 11, Quality Center, Quality Assurance, Testing, ISO, Validation, Agile, Audit, Compliance, IEC, JIRA, FDA, Software, IQ, OQ, PQ, Medical, FMEA, Functional, Acceptance, Performance, Verification
Quality Assurance Director - 13 Years of Experience - Near 60453
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
Tags for this Online Resume: Compliance, Manufacturing, ISO, Filing, Management, MDR, Process Improvement, Quality, Quality Assurance, Quality Management
Business Analyst - 14 Years of Experience - Near 20850
Tags for this Online Resume: System Security, Test, Test Scripts, Application Development, CFR Part 11, Configuration Management, Configure, Management, Monitoring, Protocol, Quality Assurance
Not Listed - 20 Years of Experience - Near 07936
SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...
Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist
Quality Assurance Specialist - 13 Years of Experience - Near 94506
SUMMARY Proficient in developing and applying Software Quality Assurance techniques and strategies to resolve problems in software and compliance with FDA regulation and ISO guidelines in Agile software development environments. Applied SQA principles and methodologies in Manual and Automated Testing with Real Time instruments. Tested instruments Firmware and Drivers. Created, modified and executed test plan and test cases....
Tags for this Online Resume: Real Time Instruments, Test Case Development, FDA, ISO standards, Visual Studio Test Management, Manual and Automated Test, Agile software development, TFS, TestTrack, C#, Python, Troubleshooting, Medical Devices Firmware, Drivers, 21CFR Part 11, Life Science, Data Analysis
Risk Management - 19 Years of Experience - Near 01845
FAMILIARITY WITH: ISO 1009, ISO 10993, ISO 13485, ISO 14969, ISO 14971, ISO 24971, 21 CFR Part 11, 21 CFR Part 820, IEC 62355-1, and HIPPA.
Tags for this Online Resume: Test, Test Plans, Quality, Unix, C++ Programming Language, C/C++ Programming Languages, Java Programming Language, Management, Quality Assurance, Software
Microbiology Quality Leader
Tags for this Online Resume: CFR Part 11, Inventory, Manufacturing, Monitoring, Microbiology, Quality, Quality Assurance, Quality Control, Research, Business Development
Business Analyst
SUMMARY Over 6 years of experience as a Business Systems Analyst in Pharmaceutical and Medical Devices industries with comprehensive understanding of GxP Regulations. Good understanding of various System Life Cycle models, Waterfall and Agile methodologies. Participated in all phases from analysis, design, and development through testing, implementation and change control. Experienced and proven ability acting as liaison be...
Tags for this Online Resume: ACD, Applications, Asset Liability Management, Asset Management, Automatic Call Distribution, Benefits, Business Analysis, Business Analyst, Business Requirements, CFR Part 11
Quality Manager - 17 Years of Experience - Near 60051
SUMMARY OF QUALIFICATIONS * Certified Master Black Belt able to lead and influence people at all levels within a Manufacturing organization. * Proficient in the DMAIC Six Sigma and DMAIC/PDCA Lean Roadmaps, including many different lean and statistical methods such as: Value Stream Mapping, 5S, Visual Management, Quick Changeover, Kaizen Events, Problem Solving, Mistake Proofing, Gap Analysis, Standard Work, Process Map, C&...
Tags for this Online Resume: Software, 5S, Complaints, Documentation, ISO, Product Development, Systems Analysis, Black belt, Kaizen, Management
Quality Assurance Specialist - 15 Years of Experience
AREAS OF EXPERTISE: * Over 12 years of experience in Computer System Validation (CSV)/Quality Assurance in the Pharmaceutical and Biotech industries including specialization in 21 CFR Part 11 Compliance. * Experience in Computer System Validation including Compliance Assessments, Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), Validation proto...
Tags for this Online Resume: Compliance, Test, Test Cases, Automation, Documentation, Protocol, Risk Assessment, Business Requirements, SAS, Test Plan
Compliance Manager - 20 Years of Experience - Near 30641
PROFILE Career-driven and results-oriented information-technology professional with a solid portfolio of managing information-technology projects as well as resolving complex technical issues. More than 36 years of progressively responsible experience and measurable accomplishments. Consistently recognized as being able to accelerate, perform, and enhance service. Strategic planner and creative-problem solver, Lead complex ...
Tags for this Online Resume: Compliance, Infrastructure, Quality, SDLC, Assessments, Audit, CFR Part 11, Geographic Information System, HP, Manufacturing, Risk Management, Project Management, SOX
