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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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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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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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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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Knowledge of GCP/GLP/GMP and quality standards. Dive into exciting pilot and pivotal studies, ensuring compliance with global regulatory standards like GLP, vGCP, and VICH guidelines. Keen interest in parasitology or significant practical experience in the discipline.
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Applies GMP/GLP in all areas of responsibility, as appropriate. Recognizes deviations from normal results and informs Study Director, Principal Investigator, and/or management of any problems and/or deviations that may affect the integrity of the data and participates in corrective action of problems.
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Demonstrates experience in CLIA, GLP, or other Research related laboratories. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities.
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Reviews simple routine and non-routine laboratory data for one or more areas according to departmental, corporate and client Standard Operating Procedures, Work Instructions, and/or Forms; read and understand analytical procedures; make sure all work is performed according to ISO17025 guidelines, GLP Regulatory, and GMP Regulatory requirements; Independent auditing of laboratory data to ensure continous compliance to both the quality system and regulatory requirements.
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7+ years of experience in quality control supporting GMP/GLP manufacturing operations. Internal services include QC training program, QC method transfer and stability program, QC data review, QC system Admin support, and management of internal QC projects.
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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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Skills: GLP (Good Laboratory Practice) Medical assistant training helpful. Performs laboratory tasks of centrifuging specimens, printing extra labels, recording data (temperature charts) specimen storage and retrieval.
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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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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.
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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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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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glp job in Indianapolis, IN
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