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Online Resumes with " FDA"
Clinical Research - 8 Years of Experience - Near 98036
Tags for this Online Resume: Seattle, Clinical Research, Administration, CRA, FDA, GCP, Research, Washington
Quality & compliance professional with 24 yrs of experience
With over 24 years of hands on experience in positions of increasing responsibility in Pharmaceutical, Bio and Medical Devices companies. Areas of expertise includes: Quality and compliance (FDA /21 CFR ,809/ICH, GxP’s), CSV (Part 11 and GAMP5) and Serialization (DSCSA), Technical Support (SME for manufacturing and quality areas), Audit in manufacturing and lab areas. Other Quality areas: revision/approval of SOP and Qualif...
Tags for this Online Resume: Quality, Compliance , Validation, Qualification, 21 CFR Part 11, Change control, CSV, 21 CFR 210,211, 809
Clinical Research - 10 Years of Experience - Near 85283
PROFILE:Handled, performed, and managed the most challenging and complex Phase One Project studies in the world involving but not limited to: Leukemia, Breast, Ovarian, and Solid Tumors in both Hematology and Oncology. Managed multi-disciplined projects and tasks involving, but were not limited to all patient responsibilities, the ordering and interpretation of all clinical tests involving Laboratory, X-Ray, CAT, and Pet ...
Tags for this Online Resume: Biotechnology, managerial, MBA, Project Management, articulated, executive operations, clinical research, clinical trials
Life Scientist - 20+ Years of Experience - South eastern Pennsylvania
Award winning, highly organized, and goal oriented Process Scientist, with extensive experience fermentation, protein purification and quality control using both microbial and mammalian expression systems. Proficient at producing materials under FDA guidelines (full cGMP’s) to support commercial manufacturing and clinical trials. Adept at working with SAP. Proven ability to instruct others effectively and efficiently. In...
Tags for this Online Resume: full cGMP’s, protein purification, fermentation, quality control, clinical trials, commercial manufacturing, South eastern Pennsylvania, microbial and mammalian expression systems
Clinical Research - 10 Years of Experience
Proactive, solution-driven professional that likes to perform assigned tasks with the best quality possible. With more than 10 years of experience in clinical research starting as Study coordinator, and being on different positions such as CRA, CRS and CPM, enjoying being part of, as well as managing, motivating and training a successful and productive team, through customer focus, team work and good relationships. Experie...
Clinical Quality Assurance - 20 Years of Experience - Near 94403
QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.
Ideal Companies: small start-up company
Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
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
Civil Engineer - 17 Years of Experience - Near 00969
Self-Motivated leader with over fifteen years of experience on the Regulated Industry and Construction including Utilities, Facilities, Manufacturing Equipment, R&D and Qualification. I have vast experience on several technologies and Project Management Techniques. Extensive experience leading maintenance and engineering personnel in cGMP and FDA regulated environment. A subject matter expert & hands-on technical experience...
Tags for this Online Resume: Florida, Facilities Manager, Project Manager, Facilities Director, Texas, Faciliies manager, Project Manager
Physician with 17 years experience in Clinical Development, Medical Affairs, Communication collaterals, Regulatory Submissions and Stakeholder and Risk Management, Consulting to the Pharmaceutical and Medical Device Industries.
I am looking for Consulting opportunities where i can apply my logical and scientific approach to finding solutions to complex problems within the confines of regulation. I thrive when I am working with likeminded passionate team players who value my strategic planning, attention to detail and ability to identify potential problems and mitigate against them early on. I have 7 years therapy experience in Oncology where I l...
Ideal Companies: Janssen, Merck, TEVA, Smaller Pharmaceutical Companies who are in a period of growth or perilaunch where I would be able to do Medical Affairs for them, Medical Device companies
Tags for this Online Resume: Medical Affairs, Clinical Development, Phase 1-4 clinical studies, Pharmacovigilance, Due Dilligence, Launch, KOL management, Risk Evaluation Mitigation strategy
Quality Manager - 20 Years of Experience - Near 27288
I am interested in finding a position in Quality where I can make a difference and put the experience and skills I have aquired in to use. Experience in Medical Device, Drug Testing, Wipes, Sterilization, FDA, EPA, OSHA, CAP, CLIA, customer complaint. Implemented cost efficiency, lean manufacturing, internal auditing, supplier auditing, supplier management programs, ISO9001, ISO13485, CAP, CLIA, NCR, MSDS and COA on line s...
Tags for this Online Resume: ASQ, Ethical, Creative, Dedicated, Accomplished, Hard working
Quality Manager - 20 Years of Experience - Near 27893
Tags for this Online Resume: 6sigma, Apqp, Internal Auditor, CAPA, ISO 9001, FDA, ISO 13485, SAFETY
