CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "21 CFR part 11"

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

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 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

Experienced Director of QA/Validaiton - 15 Years of Experience - Near 27587

Tags for this Online Resume: Validation, Software Validation, GMP, 21CFR, 21CFR PART11, Aseptic Processing,, CAPA, Quality Systems Management, Change Control, Compliance Enhancement, Warning Letter Remediation, Deviation/Exception Management,

Quality Assurance Specialist - 14 Years of Experience - Near 34685

Summary of Qualifications Over eleven years in a regulated environment including custom built applications, clinical based computer systems, IVRS systems, and data acquisition systems. Seven of those years in an IT management role. Successfully lead teams in promoting quality assurance throughout the software development life cycle (SDLC), both Waterfall and Agile/SCRUM methodologies. Successful in the development and imple...

Tags for this Online Resume: Architect, Project Management, Consulting, Quality Assurance, Software Testing, Systems Engineer, Test, Training, Account Management, sql, agile, html, software, requirements management, requirements gathering, change control, configuration management, project management, audit, management, SDLC, waterfall

Microbiologist - 20 Years of Experience - Near 80503

Summary Experienced, Self-motivated and Results-Oriented Quality professional with >25 years in the biotech/pharma and medical device industries. Experience hosting FDA and international regulatory agencies. In depth knowledge of compliance to 21 CFR parts 210 and 211, 21 CFR Part 11, 21 CFR part 820, ISO 13485, ICH Q1A-F, Q7, Q8, Q9, Q10, USP, EP, JP Testing. Knowledge and experience with GxP auditing. Chemical and Microbi...

Tags for this Online Resume: Validation, Lab Management, QMS, Compliance, Pharmaceutical, DS, DP, Research and Development, Microbiology, Manufacturing

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