CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA "

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

Mechanical Engineer - 20 Years of Experience - Near 25545

Summary I am seeking employment in a position that will make use of my diversified background in mechanical engineering. As my attached resume shows I have been able to adapt my background too many different industries. I have been directly responsible for complete project development and management including the initial engineering sales effort through project development, build, installation and equipment validation. I ha...

Tags for this Online Resume: Instrumentation, Protocol, Team Lead, Manufacturing, Engineering, Consulting, IBM, Proposal Development, Automation, Documentation

Principle / senior programmer / scientist - 20 Years of Experience - Near 98004

Professional Summary: Experienced software development professional with excellent technical, analytical and communication skills demonstrated by successful completion of numerous application software products implemented in medical device development, including cardiac monitoring and resuscitation products, from concept through implementation and final FDA submission and acceptance testing. Articulate and innovative resear...

Tags for this Online Resume: Documentation, User Documentation, VITAL SIGNS, Cardiac Monitoring, Data Analysis, Monitoring, Software, Test, Medical, Medical Devices, algorithm, scientific, FDA, Concept to V&V Testing, Innovative, imaging, ultra sound, signal processing

Biochemist - 20 Years of Experience - Near 76544

ACCOMPLISHMENTS * Senior Scientific Executive with 31 years overall industrial experience in IVD and life science industry, worked globally in United States, Canada and Europe * Developed or managed the development of over 60 successful IVD and Life Science products globally with cumulative product sales of greater than $500 million * Multi-national experience and initiation of teams specifically in United States, Germany, ...

Tags for this Online Resume: Business Development, Quality, Chemistry, Research and Development, Software, Software Architecture, Acquisitions, Cellular, Product Development, clinical, phase, trial, protocol

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

Quality Manager - 19 Years of Experience - Near 77379

Areas of Expertise: * Project Management * Continuous Improvement (LSS) * Business & Quality Process Analysis * Industrial Engineering Methodology * Quality Engineering Management * Quality/Continuous Improvement Trng. * Health, Safety and Environment Quality Management and Auditing * Manufacturing and Testing Process * Supplier Development & Management * Strategic Planning * Supply Chain Management * Budget reporting * Gov...

Tags for this Online Resume: Quality, Quality Assurance, Welding, ISO, ISO 9000, Supply Chain, Consulting, Management, API, Application Program Interface, Quality Control, Lean Six SIgma, Quality Assurance, manufacturing, production, "project management"

Senior Manager, Project Manager, Director - 20 Years of Experience - Near 60056

Summary * IT Infrastructure Senior Project Manager, engagement lead, and high-reliability business advisor. Full range of PM tools and methods as warranted by project, client, and business requirements. * Direct management responsibility for multiple pharma and hospitals compliance including: (1) SOX audits to prove IT readiness, performance, record integrity, and reporting: (2) Joint Commission on Hospital Accreditation (J...

Tags for this Online Resume: Integrate, Software, Consulting, IBM, Management, Planning, Project Management, Project Manager, Strategic Planning, Vendor Management, management

Project Manager - 20 Years of Experience - Near 60015

SUMMARY * Performance-driven, business-oriented technology professional with a record of success delivering IT solutions for core business. * PMP certified project manager experienced in FDA-regulated, information governance, data warehouse, and business intelligence systems. * Expertise in various types of methodologies such as Waterfall, Agile, Iterative, and hybrid. * Led ERP, DW/BI, GRC, and web-based systems across pha...

Tags for this Online Resume: Oracle, Business Intelligence, SAP, Supply Chain, Systems Analyst, Enterprise Requirements Planning, Legacy, Web, Web Portal, Web Technologies

Engineer - 3 Years of Experience - Near 91367

A proactive, results-oriented engineering and validation professional with experience in cGMP/FDA regulated manufacturing with educational background in electrical engineering, seeking a challenging position that offers professional growth and development. Key strengths include technical writing, process development and project planning. Certificated with a Green Belt for Six Sigma, organized, team oriented, focused with th...

Tags for this Online Resume: Engineering, Manufacturing, Market Research, Process Engineering, Quality, Quality Assurance, Quality Control, Research, Test, Test Plan

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

Clinical Regional Monitoring - 20 Years of Experience - Near 18929

Seeking an opportunity with a Pharmaceutical, Biotechnology company or CRO as a Senior Lead Clinical Research Associate, Lead CRA, CRA Manager/Trainer (Mentor) and/or CRO Oversight Monitor to employ my 27 years of clinical research monitoring, management skills and CRA mentoring as well as19 years of Respiratory/Pulmonary and Cardiopulmonary critical care clinical medicine. Clinical Research Experience: Projects/Therapeutic...

Tags for this Online Resume: Pharmaceutical, Clinical Research, Research, Rheumatology, Biomedical Industry, Pharmaceutical Industry, Cardiology, Critical Care - Neurology, Critical Care - Respiratory, Neurology, oncology, clinical, phase, gcp, protocol, trial, ich

Medical Office Manager - 5 Years of Experience - Near 27502

QUALIFICATIONS: * Promoted to the Senior CRC position as the youngest individual within the organization due to ambition, diligence, a strong team player with the ability to look at the big picture and plan accordingly. * Developed strong CRO/sponsor/vendor relationships, ensuring continuity and open communications through all phases of the trials. * Continuously reached study goals by collaboration with a diverse populatio...

Tags for this Online Resume: Cardiology, Clinical Research, CMA, Communications, Management, Medical, Project Management, Research, Triage, Research Protocols, IRB, Informed Consent, Mentoring