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Online Resumes with "GLP GCP"



Biochemist - 18 Years of Experience - Near 84037

Compliance and Quality Manager in Pharmaceutical manufacturing. Highly experienced with Aseptic, Solid Dosage, and Liquid Manufacturing including 15+ years in management. Key player in successful Regulatory relationships with Inspectors across 4 continents. Developed and implemented Quality systems, processes, procedures, and policies. People acumen across all levels from executives to entry-level.

Tags for this Online Resume: Quality, Compliance, Quality System, Standards (GMP, GLP, GCP, ICH, ISO, WHO, CE, Med Device), Training, Investigations (CAPA), Documentation, Salt Lake City

Scientist - 20 Years of Experience - Near 02446

Qin Su will continue his career as a Pathologist and Biomarker Scientist with his experience and expertise in Biomarkers, Assay Development/Validation, In Vitro Diagnostics (IVD) including Companion Diagnostics (CDx), Anatomical Pathology, Molecular Pathology, Translation Medicine and Translational Research Sciences. Expertise areas: Anatomical pathology and histopathology, board-certified.  Biomarker development, assa...

Tags for this Online Resume: Biomarker, companion diagnostics, pathology, assay development, assay validation, in vitro diagnostics, biomarker strategy, translational medicine

Senior pharmaceutical scientist with professional experience in drug safety, toxicology, biomarkers and clinical trials

Senior biomedical scientist with 14 years of pharmaceutical industry experience, in both the preclinical and clinical setting, with a focus on discovery and application of biomarkers of safety and efficacy. Served as line function expert on cross-functional project teams as well as extensive experience in leading specialty sub-teams. Excellent analytical, verbal and written communication skills, with extensive experience in...

Tags for this Online Resume: drug safety, biomarkers, clinical research, clinical trials, toxicology, data analysis, scientific writing

Clinical Quality Assurance -13 Years of Experience - Near 92121

Experienced Document Control Associate for the pharmaceutical, device and technology industry working in a GLP, GCP, and cGMP environment. Demonstrated project manager for several document management types, with ability to self-prioritize to meet management and customer demands. Responsible for the successful execution of change control activities for all document types. Effective communicator with strong grammatical, wr...

Tags for this Online Resume: San Diego, CA, GLP, GCP, cGMP, Document Control, Quality Assurance

Biologist - 5 Years of Experience - Near 60608

Summary * 10 years research experience, broad scientific knowledge with solid publications. Lead projects from initiation, planning, design, and execution to publication * Daily responsibility in optimizing conditions, developing protocols and training graduate students * Strong R programming skill, familiar with statistical inference and regression modeling * Familiar with bowtie2, tophat, cufflink, samtools and rMats for ...

Tags for this Online Resume: C Programming Language, Cancer, Data Analysis, Data Processing, ELISA, EMT, Extensible Markup Language (XML), Genotyping

Featured Profile

Senior Business Systems Analyst/IT Project Manager - 7+ Years of Experience - Chicago IL

Strategic and innovative Senior Business Systems Analyst/IT Project Manager with over 7+ years� experience leading large scale IT projects. Highly accomplished and forward-thinking, with diverse expertise in IT systems and business systems analysis. Talented senior system analyst and senior business systems analyst with broad IT experience across multiple sectors. Create, design and implement efficient, consistent and strea...

Ideal Companies: Baxter, Takeda, JP Morgan Chase, Citibank, HSBC, Allstate, Bank of America, Standard Chartered, State Farm, Johnson & Johnson, Procter & Gamble

Tags for this Online Resume: Business Requirements to System Design, Laboratory/QA Systems like LIMS, Empower 3, ELN, Atlas, SDMS NuGenesis Configuration/testing, Regulatory Compliance for FDA, EU Annex 11, 21CFR Part11 Compliance, ERP SAP-QM, SDLC/Waterfall/Agile Development Methodologies, Project Management, Custom Software Development, Systems Engineering, System Risk Mitigations/Integrations, Enterprise wide implementation, ROI Analysis, Costing , UAT, System Integration Testing, Performance Testing, Regression testing, Acceptance Testing, Validation Testing Scripting and documentation. GXP, GMP, GLP, GCP, Lean Six Sigma Green Belt expertise, C, Oracle 10g/11g, SQL Server, PL/SQL Stored Procedures, Costing, Project Scheduling, Cross-Functional Supervision, Team Building, Client Relations Presentations, Business/IT Planning, Vendor Management, UML Designing, MS Project, Gantt Chart, MS Office, Rational Rose, URS, FRS, SDD, Installation, Traceability Matrix, BI, Cognos, QlikView, Infomaker Report, MS Test Manager, Sharepoint, Business Operation Excellence, Process Improvement Excellence

Quality Engineer - 19 Years of Experience - Near 77459

SUMMARY Highly motivated, goal oriented, and efficient Quality Assurance professional with expertise in regulatory compliance, documentation, auditing, and process improvements. Known for ability to complete multi-faced tasks within strict time constraints. Demonstrated expertise in setting priorities and establishing appropriate detailed documentation to meet deadlines using strong clinical, analytical, and technical skill...

Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Audit, Complaints, ISO, ISO 9001, Management, Protocol, Manufacturing, ISO 13485

Life Scientist

Professional Summary Objective: A passionate, creative and result-oriented interdisciplinary scientist, committed to scientific excellence and innovation in Research & Discovery of Biologics and Biotherapeutics Accomplishments: * Accomplished author and reviewer of scientific contributions in peer-reviewed journals. * Presented scientific results within cross-disciplinary teams, meetings and conferences. * Trained/mentored ...

Tags for this Online Resume: New Jersey, Vendor Management, Interdisciplinary Scientist, Technical, Leadership, Collaborative team builder,, Life Science Manager, R&D, Biologics, Good Practices in Health and BioSafety, GLP, Database, Bioinformatics, Computer skills, Microsoft Office tools, Adobe, Scientific/Technical/Computational Skills, Accomplished author, Technical writer and reviewer, Genomics

Clinical Regulatory Affairs - 20 Years of Experience - Near 55311

Summary of Specialized Skills * Design, development and conduct of device based Clinical and Pre-Clinical Research projects. * Experience in writing various clinical documents, including protocols, CERs, reports, research findings. * Design and Implementation of various Pre-clinical trials for pilot studies of various implantable technologies. * Management of scientific/animal studies and clinical projects. * Hands-on exper...

Tags for this Online Resume: Imaging, Cardiology, Integrated Development Environments, Management, Data Management, PACEMAKER, Pacemakers, Research, Clinical Research, Publications

Life Scientist - 15 Years of Experience - Near 77573

Professional Summary Strong management skills with 15+ years' experience in designing, managing and execution of scientific and clinical research projects resulting in acquiring lab funding for Principal investigators. * Confident communicator with solid track record of 9 publications in well-respected journals, one book chapter and 20+ presentations at national and international conferences. * Demonstrated ability to deliv...

Tags for this Online Resume: Documentation, Clinical Research, Management, Project Management, Research, Data Analysis, Diagnostics, Drafting, Neurological, Problem Solving, Good Clinical Practices, Project Planning, Critical Thinking, Molecular Diagnostics, Leadership, Team Player, Technical support, Presentation, Scientific writing, Immunology, Training, Neuroscience, Pharmacology, Microbiology, Parkinson's disease, CNS, Life science, Customer demonstration