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Online Resumes with "GLP "
Director / Manager Quality Assurance
Apply my skill sets to promote regulatory compliance of your research business!
Tags for this Online Resume: Compliance, Quality Assurance, Scheduling, Test, Toxicology, Management, Audit, Corrective Actions, Due Diligence, protocol, pharmaceutical, ich, gcp, phase, GLP, Bioanalytical
Quality Coordinator
SUMMARY: * Analytical Chemist with over ten (10) years of R&D, Quality Control/Quality Assurance and performance experience in diverse areas of chemistry including pharmaceuticals and food products. * Thorough knowledge of theory, use, simple repair and maintenance of typical analytical instrumentation including HPLC, GC, FTIR, UV/VIS AND Dissolution. * Excellent ability to identify compounds based on spectrochemical and /o...
Tags for this Online Resume: Documentation, Control Data, High Performance Liquid Chromatography (HPLC), Pharmaceutical, Chemistry, Instrumentation, Quality, Quality Assurance, Complaints, Management
Clinical Regulatory Affairs - 6 Years of Experience - Near 92648
QUALIFICATIONS Document-Labeling Specialist, Nov.2015 - Feb.2016 Well-versed communicator, high organizational and analytical (Contract Position Only) abilities. Work well independently and as a member of a * Creation, Revision of CGL, pre-printed labels and IFU via team. Adept in SUSARs, IRB submissions, Sponsor redlining documents and SOP standards. monitoring, and CTMS files. Efficient at handling multiple regulatory doc...
Tags for this Online Resume: R programming, Word, Excel, Adobe Photoshop, Illustrator, google analytics, github, Adobe, Data Entry, Documentation, ISO
Department Manager
Qualifications Profile Seasoned, highly effective, and dynamic cross-functional leader, offering comprehensive experience in lean manufacturing and engineering operations, project management, and research and development (R&D) across the science and technology fields. * Performance-focused and armed with tactical leadership and exceptional organizational capabilities in managing teams toward the successful and timely comple...
Tags for this Online Resume: Research, Chemistry, Science, Analytical Chemistry, Budgeting, Compliance, DSC, Engineering, Good Laboratory Practices, Good Manufacturing Practices
Quality Assurance Director - 18 Years of Experience - Near 55379
Summary of qualifications Global Quality System and Regulatory Compliance Experience in Regulated Environments (Medical Device/Pharmaceutical/Food/In-Vitro Diagnostics) including implementation of design controls * Global Regulatory and Quality Compliance (creating processes for Field Actions/point of contact for all recalls with the FDA/806 and monthly reporting) * Regulatory partnering with FDA and International Agencies ...
Tags for this Online Resume: Documentation, Infrastructure, Management, Program Management, Budget Preparation, Budgeting, Development Activities, P&L, Product Development, Project Management
Analytical Chemist
A challenging position as a scientist utilizing my science background and ten years GMP/GLP laboratory experiences.
Tags for this Online Resume: HPLC, Analytical , LC/MS, Mass Chromatography, GMP, UV/Vis
Analytical chemist - 15+ years eperience HPLC, LCMS; pharma-biotech
HPLC and LCMS method development and validation in support of small molecule drug discovery programs, reglatory submissions, or related area
Tags for this Online Resume: HPLC and UHPLC, LCMS and LCMS/MS, analytical chemistry, method development and validation, cGMP and GLP, regulatory submissions
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 Assurance Manager / Vendor Manager - 20 Years of Experience - Near 60060
SUMMARY: Experienced, dedicated, Quality Assurance professional and trainer who provides the knowledge and skills to assist with and drive projects as part of a team or as an individual contributor. * 20+ years of experience in pharmaceutical research, 15+ in Quality Assurance * Experience with Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH), Good Laboratory Practice (GLP), Vend...
Tags for this Online Resume: Quality Assurance, Test, Clinical Research, Research, Audit, Management, Pharmaceutical Industry, Development Activities, Policies and Procedures, Vendor Management, Clinical, GCP, GLP, Training, Nonclinical research, Preclinical, Early phase clinical research
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
Chemist - 12 Years of Experience - Near 64131
Profile Prepared proposals/quotations studying the feasibility of scale-up process. Business development, supervising junior colleagues, technical oversight, custom synthesis. Execution of complex multistep syntheses of small molecules, polymers, following GLP and GMP guide lines. Extensive knowledge using SciFinder and ChemDraw programs.
Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Research, Chemistry, Cancer, Derivatives, Business Development, Certificate Authority, Evaluate, Good Laboratory Practices, Good Manufacturing Practices
Chemical Plant System Operator - 20 Years of Experience - Near 08753
SUMMARY: Over Thirty years' experience in positions of increasing responsibility within the Pharmaceutical and Consumer Divisions of Johnson & Johnson, FMC and Cardinal Healthcare, have provided the opportunity to develop a strong knowledge of FDA, GLP Guidelines, Practices and GMP's as set forward in the Quality System Regulations (Section 820 of The Act). Skilled in both Production Floor, Pilot Plant and Laboratory Enviro...
Tags for this Online Resume: Research, Consumer Products, Medical, Medical Devices, Notebook Computer, Product Development, Wound Care, Quality, Amaps (Mrp/Cim Sw), manufacturing, production
