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Online Resumes with "FDA Inspections"
Clinical Research - 14 Years of Experience
ACCOMPLISHMENTS ACROSS THE CAREER * Successfully manage global CRO within a short span time - turn around trial performance. * Achieved 50% surge in recruitment and ensured recruitment rate for 20+ months by turning around in a challenging trial in an oncology area. * Implemented recruitment strategy in an on-going trial that resulted in 100% achievement to planned patient recruitment in a rheumatology indication. * Bagged ...
Tags for this Online Resume: Management, Planning, Project Management, Project Manager, Proposal Development, Quality, Quality Assurance, Test
Director of Quality - 15 Years of Experience
SUMMARY Certified Quality Auditor for Life Science Practice Lead as senior Quality System Auditor with compliance acumen delivering outstanding returns through comprehensive knowledge and hands on experience. Vendor qualification and management plus remediation efforts ensuring delivered products meet requirements for direct to stock fulfillment. Certified Quality Auditor/Project Manager for Quality Management Systems for m...
Tags for this Online Resume: Audit, Quality, Quality Assurance, Services, Test, Compliance, Infrastructure, Management, Risk Management, Training
Clinical Regulatory Affairs - 20 Years of Experience - Near 53143
Summary 30 plus years in the Medical Device and Pharmaceutical industry. Extensive expertise in Supply Chain, Customs Compliance (import and export), Test methods and Process Validations, Technical product development and support, GTIN and UDID process for organizations that meet GS1 standards. Experience in Customs Compliance and Quality Systems Regulations as well as domestic and international standards. Core competencies...
Tags for this Online Resume: Customs Compliance, Scrum Master, Regulatory Affairs, Validation, HR, Quality, Compliance, Hepatitis, Planning, Quality Assurance, Project Manager, Medical devices
Department Manager
Summary of qualifications Professional experience Managing Director of TSB Management Consultants, working with a network of specialists and working out of a toolbox gathered in 29 years of engineering, maintenance and operational experience. Proponent of lean approaches to all and uncompromising Safety expectations. Hope to provide expert services to small manufactures in Safety, Operations and Compliance, focusing on west...
Tags for this Online Resume: P&L, CCL, Engineering, Kaizen, Retail, Schematics, 5S, Audit, MOS, SAP MM module
Quality Manager - 16 Years of Experience - Near 30038
SUMMARY Highly motivated Quality Professional with over 15 years' combined working knowledge in Quality System Regulations (QSR), Quality Management System (QMS), FDA Inspection Readiness, and Systems Based Auditing with varied cGMP, cGLP, Nonconformance and CAPA Management experience. Experience in regulated environments for Pharmaceutical, Medical Device, Biologics and Bio-Chemical industries. Demonstrated strengths in or...
Tags for this Online Resume: Complaints, NCR, Test, Audit, Facilitator, Green Belt, High Performance Liquid Chromatography (HPLC), Logistics, Quality, Quality Assurance, Corrective action preventive action, steel, mechanical engineer, die cutting, machine operator, electrical engineer, CAPA, Risk Analysis, FMEA, Control Plans
Director of Quality & Regulatory- 22 Years of Experience - Near 45142
Summary Twenty-two years in the Medical Device Manufacturing Field, including 16 years of Director level experience in Quality Managements Systems, Regulatory Affairs and Quality Assurance/Quality Control Activities. Knowledge and professional experience in the following areas: Quality, Engineering and Manufacturing Implemented practical oversight of the following: * ISO13485 * ISO9001 * 21CFR820 (FDA) * ISO14971 Risk Manag...
Ideal Companies: A company with suability, growth and development of their employees.
Tags for this Online Resume: Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory
Clinical Regulatory Affairs - 2 Years of Experience - Near 02215
PROFESSIONAL SUMMARY: A Regulatory Project Manager with 2+ years of managing IND/NDA/BLA review processes and 1+ years of cGMPs experience in pharmaceutical industry. Deadline-driven and highly reliable professional, successfully managing over 300 applicants' submissions in IND, NDA, BLA, and BSE as well as participating in 4 cGMPs sponsors' inspections (Japan and Taiwan) and 1 FDA inspection at manufacturing plants. Great ...
Tags for this Online Resume: Compliance, Pharmaceutical, Project Management, Regulatory affairs, CMC, NDA, IND, BLA, cGMP, GCP, ICH
Quality Coordinator
Provided * Provided coverage for 2 facilities and investigator research assistance in 2 locations * Maintained Rodent, Non-Human Primate, Beagle, Rabbit, and Hound Colonies. * Reviewed GLP documentation for up-coming FDA inspections * Reviewing protocols and assisted investigators in Toxicology and Metabolism Groups emergency coverage for 2 facilities and investigator research assistance on 2
Tags for this Online Resume: Surgical, Inventory, CT, Inventory Control, PET, Spreadsheet, Toxicology, Welding, Documentation, HIV
Quality Manager
MAJOR ACCOMPLISHMENTS: * Instrumental in increasing approximately $3 Million in revenues in the first year by developing and implementing a novel UV curing process to terminate stimulating hydro-gel used in the manufacture of neuro stimulating and sensing electrodes. * Saved approximately $2 Million in the first year by eliminating scrap, returned devices, customer complaints, legal suits and consulting fees by changing and...
Tags for this Online Resume: Documentation, Manufacturing, Quality, Quality Assurance, Quality Control, Complaints, Test, Audit, Fraud, Health Insurance
Chemist - 15 plus Years of Experience
SUMMARY An analytical scientist with 10 plus years in the pharmaceutical research and testing industry. Have supervised up to seven people and trained new and experienced scientist. Been responsible for the generation and review of data, reports and the release of reports. Oversaw the inventory of controlled substances for the departments and interacted with the DEA and FDA for inspections and audits.
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Research, Good Laboratory Practices, Good Manufacturing Practices, Analytical Chemist
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
Microbiologist
PROFESSIONAL SUMMARY * Experienced Compliance Reviewer, Quality Control and QA Specialist. * Manufacturing professional with 17 years in GMP controlled manufacturing suites and lab environment seeks a position offering professional growth and stability. * Thrive in challenging environments and am always seeking new ways to improve workplace efficiency. * Skilled in validation of laboratory instruments including those with c...
Tags for this Online Resume: Test, Manufacturing, Quality, Quality Assurance, Quality Control, Documentation, High Performance Liquid Chromatography (HPLC), Pharmaceutical, Software, Compliance
