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Experience in Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) Managing programs to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and DEA.
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Applies quality practices (GCP, GLP, GMP, GDP, ISBER) to positively impact environmental/research compliance and quality of samples used in research. One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at IU School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services.
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DepartmentGENE THERAPY TESTING LAB (IN-GTTL-IUINA)Department InformationOne of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at IU School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services.
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Broad knowledge of good laboratory practices (GLP) and good automated laboratory practices (GALP). Broad knowledge of principles and practices of analytical, organic and inorganic chemistry with subsequent experience during the last 2 years.
$31 an hourExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Perform preventive maintenance, service, calibration, set up and repairs on process instruments and related systems associated with GMP/GLP process related equipment. Understand sophisticated technical equipment, fixing documents and determine the appropriate usage and operate all client standards test equipment including but not limited to Fluke temperature and volt ohm meters, Calibrators, Signal Generators and Oscilloscopes.
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Expose to regulatory requirements such as GLP, CLIA, etc. Understanding of Molecular Biology, Bioinformatics, or related field of biology is a plus. We are seeking a Java full stack developer to be apart of our dynamic drug development team.
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Knowledge of global regulatory guidance (e.g. ICH and geography-specific guidance's) and Good Laboratory Practice (GLP) standards. Toxicology representative on diverse scientific teams, working collaboratively across multiple functions including Chemistry, Discovery Biology, Drug Disposition, Pathology, Medical/Clinical, and Regulatory Affairs within Lilly and with external research organizations.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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You will conduct work in compliance with cGMP/GLP, safety and regulatory requirements. In more than 100 countries, we offer the industry’s most comprehensive in vitro diagnostics solutions, covering molecular diagnostics, clinical chemistry and immunoassays, tissue diagnostics, point of care testing, patient self-testing, next-generation sequencing, and laboratory automation and IT, and decision support solutions.
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Maintain accurate and detailed records of all testing and analysis activities in compliance with GMP, GLP, and GDP. Perform gamma spectroscopy and analyze results as needed. Our client is seeking a QC Analyst at a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals.
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Adhere to FDA Good Practices (GMP, GTP, GLP, GDP), International Organization of Standards (ISO), College of American Pathologists (CAP) standards and other regulatory requirements as outlined in SOPs.
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Practical knowledge of laboratory safety and biosafety. Specialized knowledge of related scientific areas such as information systems, physics, and statistics. Ability to assist with epidemiological and/or statistical reports from data compiled on a daily, weekly, monthly or annual basis.
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Deep understanding of analytical sciences, drug development process, GMP/GLP requirements, and pharmaceutical industry trends. Perform non-routine analytical activities by independently developing and characterizing stability-indicating methods for early-phase pharmaceutical small to medium molecules with pre-set timelines using instrumentation such as, but not limited to, UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, and KF titration.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Maintain up-to-date knowledge of GLP/GMP and Computer Systems Validation (CSV) requirements through training and participation in external forums. Responsible for ensuring all laboratory equipment/software, IT systems and associated infrastructure, within the R&D GLP environment, GMP manufacturing (as applicable) and cloud environments, is in a qualified, validated state by supporting management, creation and review of validation activities.
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Ensure all documentation complies with industry standards and regulatory requirements, including FDA, GMP, and GLP guidelines. Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more.
Full-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Document all experimental procedures in line with Good Laboratory Practices (GLP) and company SOPs. Conduct routine and specialized testing of pharmaceutical products using techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Vis Spectroscopy, and other analytical instruments.
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