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Understand principles of Quality Management System, including requirements of Current Good Manufacturing Practice (CGMP), Good Documentation Practice (GDP), Good Laboratory Practice (GLP), Quality System Regulation (QSR), United States Department of Agriculture (USDA), and International Organization for Standardization (ISO) 13485.
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Serve as a Study Director for non-GLP and GLP-compliant Medical Device efficacy and toxicology studies. The company offers integrated preclinical drug development services including cellular and animal disease model design and development, non-GLP and GLP efficacy, toxicity, biodistribution, and product release studies in a broad range of animal species.
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Comprehensive knowledge of GLP regulations, including previous GLP experience in pharmaceutical or biotechnology industry or equivalent GXP transferable experience. Oversee and provide strategic direction for Toxicology/Pathology, BioAnalytical/DMPK, Biomarkers, and Clinical Pharmacology teams to ensure robust support for clinical development programs.
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We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.
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Study Directors are responsible for the interpretation, analysis, documentation, and reporting of study results for GLP and non-GLP studies. The Study Director, Research Scientist will have a passion for preclinical research.
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Charles River Insourcing SolutionsSM can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment.
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In-depth knowledge and experience with GLP and/or GCP regulations and industry standards (EPA, OECD, FDA, EU guidance) Duties carried out in accordance with the HistoWiz QMS and Standard Operating Procedures (SOPs) to support GLP and non-GLP work.
$120,000 - $150,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Laboratory work should be conducted in accordance with GLP, the Institute Animal Care and Use Committee (IACUC), and the American Association for Laboratory Animal Science (AALAS) Maintain SOPs for review and approval by Capability Area Manager and monitors compliance with DoD/Army safety procedures and Good Laboratory Practice (GLP), Clinical Laboratory Improvement Amendments (CLIA), Clinical Laboratory Improvement Program (CLIP), and the College of American Pathologist (CAP) regulations.
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AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. The Data Coordinator is responsible for maintaining study files, reviewing data in real time, and ensuring that SOP, Protocol, and GLP requirements are met.
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Keywords: sample management,GMP, GLP, GXP, GCP, deviations, quality assurance, FDA REMS, quality control, aseptic technique, Smartsheet, CAPAs, risk management, change controls, deviations, biotechnology, pharmacovigilance, pharmaceuticals, quality management, QMS, WWPS, aseptic gowning, good manufacturing practices, good documentation practices, biology, chemistry, life sciences.
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Other: Understanding of operating LCMS/GMS instruments and other typical small laboratory equipment, ability to manage multiple projects and prioritize work to meet deadlines, capable of data interpretation of biotherapeutics (metabolites, peptides and proteins, oligonucleotides) using analytical software (i.e. Analyst and Chromeleon), ability to learn Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate.
$85,000 - $100,000 a yearExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Bioanalytical Chemistry supports the evaluations of test compounds by providing bioanalytical quantitative analysis of drug in body fluids and tissues from non-regulated and regulated studies including preclinical safety evaluations, pharmacokinetic/pharmacodynamic studies, and clinical trials.
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CTG is seeking to fill a GLP Technician - Analytical opening for our client in Pleasanton, CA. Working in a regulated lab environment such as GLP, GMP, and with EPA/FDA GLP or GMP method validation and product characterization.
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Knowledge of laws, regulations, policies and guidelines that govern animal research, research conduct principles and current methodology of laboratory animal medicine and management required. ACLAM eligibility or accreditation is highly desired.
$160,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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QC Chemist will perform, under the direct supervision of the Director of QA/QC, inspection and analysis on raw materials, in-process samples, and finished goods to ensure compliance with cGMP/GLP/ISO standard operating procedures.
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glp job Title: analytical Company: Pci Services
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