CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "21 CFR Parts 210 "

Quality Engineer - 20 Years of Experience - Near 30022

I have been involved with numerious FDA regulated manufacturers in both the pharmaceutical as well as the medical device industry sectors in supporting them in meeting their FDA warning letter violations. These directives encompass 21 CFR Part 210 / 211 and 21 CFR Part 803, 806, 809 & 820 compliance statues. I pride myself in assisting team members in not only understand what the FDA is asking of them, but to enhance the ...

Tags for this Online Resume: quality assurance, regulatory compliance, engineering

Engineer - 20 Years of Experience - Near 94565

Henry Martinez has twenty-six years’ experience in the areas of Advanced Control Systems, Instrumentation Specialist, Quality Assurance, Design and Diagnostic set-up for R&D experimentation. During that time he worked on High Profile Projects under the SDI (Strategic Defense Initiative) and the Brilliant Pebbles Programs supported and funded by DARPA (Defense Advanced Research Projects Agency). During the past 15 years, he ...

Tags for this Online Resume: Validation Engineer, Packaging Engineer, Controls Engineer, BMS, Compliance, FDA

Quality Engineer - 14 Years of Experience - Near 91016

 Over14 years of in-depth experience in the pharmaceutical industry.  Highly analytical thinking with demonstrated talent for identifying, scrutinizing, improving, and streamlining complex work processes.  Experience in Quality Systems and Manufacturing Operations, Change Control, Process Validation, Documentation, Manufacturing and Maintenance systems utilizing cGMP, industry standards and lean manufacturing approaches...

Tags for this Online Resume: QUALITY, SUPERVISOR, MANUFACTURING, PHARMACEUTICAL , HARD WORKER, RESPONSIBLE, SQL, LIMS, Distribution, Documentation

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

Chemist - 11 Years of Experience - Near 30904

Professional Summary Pharmacist with doctorate degree in analytical chemistry with hands on experience in analytical method development and its validation. Expertise in material chemistry (sol-gel chemistry) and column technology. Have skills and ability to operate wide range of analytical instruments and have basic knowledge of GMP, GLP, 21 CFR Part 210, 211 and validation studies. Currently working in a pharmaceutical ind...

Tags for this Online Resume: Chemistry, Inventory, Pharmaceutical, Regulatory Affairs, Analytical Chemistry, Good Laboratory Practices, Good Manufacturing Practices, High Performance Liquid Chromatography (HPLC), Instrumentation, Its

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

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

Supervisor

Mr. Thomas M. Golden is a Senior Validation Engineer with 25 years of experience in the pharmaceutical and biotech industries. Mr. Golden has extensive experience in both management and team player roles in utilities process development scale ups technology transfer cGMP GDP SOPs FDA regulations and critical utilities. He has excellent oral and written communication skills and is an innovative leader who believes in teambui...

Tags for this Online Resume: Manufacturing, Procurement, Utilities, Packaging, Protocol, Acceptance Testing, Management, Pharmaceutical, manager

Production Manager - 20 Years of Experience - Near 32825

PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...

Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management

Not Listed - 17 Years of Experience - Near 53562

Areas of Expertise * Quality Engineer * Non-Conformance * Auditing * Product Surveillance * Training & Staff Development * Medical Device & Pharma * Complaint Review * Policy & Procedures * FDA/MDR Reporting * Subject Matter Expert * Complaint Investigation * 21CFR Part 210 and 211 * 21CFR Part 820 and 803 * ISO 9001, 13485 & 14001 * Laboratory Testing * Calibration and Validation * Federal Compliance * International Compli...

Tags for this Online Resume: Quality, Quality Assurance, Systems Operations, Documentation, Instrument Calibration, Notebook Computer, Project Coordinator, Process Improvement, Typing, Inventory, human resources

Chemist - 8 Years of Experience - Near 08855

SUMMARY: * Over 16yrs pharmaceutical experience in Quality Control, Stability and R&D, Drug development & approval, sterile injectable pharmaceutical manufacturing, solid dosage manufacturing, aseptic techniques, and clinical packaging/ labeling for top pharmaceutical companies. * Solid background in Instrumental Analysis and GMP compliance. Expertise in hands-on use of instrumentation such ICP, GC/MS, HPLC, LC/MS, UV, and ...

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Research, SEC, Securities and Exchange Commission (SEC), Support, Instrumentation, Audit, Good Laboratory Practices, Good Manufacturing Practices, oncology, phase, protocol, pharmaceutical, clinical

Quality Coordinator - 5 Years of Experience - Near 08817

PROFESSIONAL PROFILE SUMMARY * A Quality professional with over twenty years' experience in Pharmaceutical and Biotechnology industries. Expertise in pharmaceutical, biological and aseptic manufacturing of sterile injectable and non sterile drug products with an emphasis on regulatory compliance including deviation review (laboratory and production), FDA inspection readiness, quality systems and cGMP compliance. Implemented...

Tags for this Online Resume: Management, Compliance, Reviews, Pharmaceutical, Audit, Documentation, Quality Assurance, Test, Manufacturing, manufacturing, production, reliability, mechanical engineer, electrical engineer, machine operator, maintenance, die cutting