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Online Resumes with "US FDA"



Postdoctoral Researcher - 10years of experience - US FDA, CDC

Seeking a challenging and rewarding career in Biomedical industry.

Featured Profile

Quality Assurance Associate Managert

Quality Assurance professional with problem-solving abilities in Pharmaceutical and Biotechnology industries. Primary strengths include US (FDA) 21 CFR, and ICH Q7A Guidance for API Manufacture, Quality Systems development and implementation and strong auditing skills. Introduced and managed electronic document management software including validation, implementation, and maintenance, as well as project team leadership. R...

Tags for this Online Resume: Quality Assurance, FDA regulations, CAPA, Document Control, Change control

Featured Profile

Materials Director - Operations Director - Operations Manager

Progressive - Team Building Manager Objective - Attainable - Far Reaching Goals Strong Horizontal and Vertical in depth experience. Always open to new ideas, thought processes, mechanisms.

Ideal Companies: Healthcare manufacturing, biopharmaceutical organizations

Tags for this Online Resume: Experienced Sr Manager, Manufacturing, Purchasing, Surgical, Wireless, Engineering, Management, Pricing, Quality, Quality Assurance

Chemist - 20 Years of Experience - Near L5W0C1

I have been involved in research in the bioanalytical field as well as worked in preclinical/clinical studies in the drug discovery process which include anticancer, antihistamines, specific target pain relievers and others. I have more than 20 years experience in bioanalytical chemistry which includes preclinical/clinical assays, research in a GLP/GMP environment. I have managerial experience in setting up and running of...

Pharmacist

Tags for this Online Resume: Regulatory submission, CMC, cGMP, Compliance, Regulations and Guideline, US FDA, medical device, IND/NDA/ANDA

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

Featured Profile

PhD with Clinical Research Training and 5 years research experience - seeking Clinical Research and MSL related positions

Highly driven and dynamic scientific professional, strategic and analytical in processing and integrating scientific and clinical information. Fast learner who thrives under challenging and demanding situations with steep learning curves. Excellent written and oral communicator with an established record of effective and influential presentations at key international conferences and won best oral presenter/presentation awar...

Ideal Companies: Roche, Johnson & Johnson, Pfizer, Genentech, GlaxoSmithKline (GSK), Sanofi, Novartis, Bristol-Myers Squibb, Abbott, Bayer, Merck & Co., AstraZeneca, Amgen, Lilly

Tags for this Online Resume: Scientific Expertise, Written and Oral Communication, Leadership qualities, Time Management, Clinical Research, Scientific Liaison, PhD, Relocatable

Pharmaceutical Quality Assurance Specialist- 10 years Experince- Atlanta

Seeking a challenging assignment in Quality Assurance in the pharmaceutical sector to utilize acquired expertise and deliver best-in-class results. PROFESSIONAL SNAPSHOT: •A Quality Assurance Professional bestowed with 10+ years of experience in Corporate Quality Assurance, Plant Quality Assurance, Manufacturing, Validation and different International Quality audits in Solid Dosage. •Hands on experience with Quality Manage...

Tags for this Online Resume: QMS, Batch Record Review, Preparation of SOP, CAPA, Investigation, Change Control, Deviation, Internal Audit, Document Control, Batch Release, Solid Dosage, Process Validation, APQR, Market Complaint, GMP, OOS, Self Inspection, Third Party Audit

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

Chemist - 7 Years of Experience - Near 01603

SUMMARY OF EXPERIENCES & SKILLS: * Nine years of experience in Biochemistry. Primary area of expertise is HIV/AIDS research. * Very good familiarity with and certification in Good Clinical Practice (GCP) Familiarity with US FDA and EMEA guidance on clinical research * Master's degree work on determination of Human Immunodeficiency Virus-1 serotypes * Other areas of expertise include molecular biology, immunology, organic ch...

Tags for this Online Resume: Clinical Research, Electrophoresis, ELISA, HIV, Research, Budgeting, Financial, Financial Management, Inventory, Inventory management