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Relevant experience in good laboratory/manufacturing practices (GLP/cGMP), laboratory quality control or stability, and interaction with quality assurance is required. Perform routine ICP-MS and ICP-OES analysis for trace metals in a GMP analytical laboratory.
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Performs Cell Culture and Cell-Based assays (BSL2 and BSL2+) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs.
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Compliance Adherence: Ensure strict site adherence to regulatory requirements, including implementing SOP's, US FDA Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) under preclinical to clinical grade testing.
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Maintain data integrity and ensure compliance with company SOP's and specifications, FDA, GLP. CSR and cGMP regulations investigate deviations and write exception documents. Will understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.
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Familiarity with cGMP, Good Laboratory Practices (GLP), and project management principles. Bachelor's degree in Pharmaceutical Science, Chemical Engineering, Food Science, Chemistry, or a related scientific discipline.
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May serve as study director, principal investigator, or project leader for GLP and CGMP studies. Completes complex work for research and development, CGMP and GLP studies and documents and reports data in a timely manner according to regulatory guidelines.
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The RII operates a complete cGMP/GLP production facility to produce PET radiopharmaceuticals for human clinical and translational research. This position requires the successful candidate to be an adept, hands-on chemist with experience in organic, inorganic, analytical, or radiochemistry, preferably with experience in short-lived radioisotopes.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Compliance with, and knowledge of, regulatory guidelines and company SOPs (CGMP, GLP) is required. Experience with protein characterization, including peptide mapping and intact mass by LC/MS.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Understand Quality Systems Regulations, cGMP/GLP regulations, ICH Q7, and FDA requirements for pharmaceuticals and medical devices. Assesses compliance with cGMP regulations on difficult and complex technical issues.
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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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Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS Has demonstrated competence in conducting chemical analyses Good knowledge of wet chemistry techniques In-depth working knowledge of laboratory software and chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax) Competency in Microsoft Office Suite P#1 Email resumes to Jacqueline.
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Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
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Performs a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures.
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Document all testing activities in accordance with cGMP.Performs duties according to LSS Global direction and in compliance with cGMP and GLP regulations and SGS Integrity programs. Job DescriptionThe Chemist I, Extractable & Leachable will perform material extractions, standard solution, and sample preparations to support GC-MS/FID and/or LC-MS/PDA and/or ICP-MS/OES analysis on extractable and leachable (E&L) testing of pharmaceutical containers and medical devices.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Complete professional level chemistry and biochemistry assignments independently in support of programs, and investigations with minimal supervision while demonstrating cGMP and scientific principles.
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