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The Laboratory Technician I performs cell culture and cell-biology based assays 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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The Senior QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements.
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The incumbent will provide leadership for the performance of the Small Molecule, Large Molecule and Central Lab functions at the WuXi NJ site, lead the team in bioanalytical sciences, GLP operations, and business aspects, and to collaborate with WuXi’s Bioanalytical and Central Labs in China to promote synergy in supporting global clinical and non-clinical studies.
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Defines strategy for and oversees tactical execution strategic plan by direct reports to provide effective oversight of research, assay development in support of pre-clinical and clinical research, GLP animal studies, in vitro diagnostic development, and all R&D vendors.
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As the QC supervisor, you will be accountable for ensuring that the work performed by the QC laboratory personnel is accurate, timely, efficient, and compliant with company policies, safety regulations, quality SOPs, cGMP, GLP regulations, and FDA regulations.
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Perform all assigned tasks in a timely and organized manner in accordance with cGMP, GLP, and company policies and procedures. Experience with NMR, ICP-MS, XRPD, DSC-TGA, LC/MS and/or GC/MS preferred.
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Serve as the subject matter expert on cross-functional teams to lead projects, direct GLP bioanalytical validations and sample analysis across all nonclinical, DMPK and clinical pharmacology development.
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Innovative Environmental Services (IES) Ltd is a GLP-certified Contract Research Organization (CRO) with its headquarters in Witterswil, close to the city of Basel in Switzerland. Experience in a CRO working under GLP in analytical chemistry of advantage.
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Conduct bioanalytical sample analysis for non-GLP and clinical studies. Understanding GLP and GCP regulations as relates to bioanalysis. Prior experience and good understanding of cell-based assay development, cell culture techniques and flow cytometry methods are desired.
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Stagebio.com) is a leading global provider of GLP-compliant clinical research and preclinical necropsy, histology, pathology, image analysis and specimen archiving services for the biopharmaceutical, medical device and contract research industries.
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In-depth expertise in test method development, method qualification/transfer, and characterization of small-molecule drugs during preclinical (GLP toxicology) and early-phase clinical development.
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Skills: HPLC, MS-WORD, MS-EXCEL, MS-Powerpoint, Analytical Chemistry, Chemistry, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice) skills: HPLC, MS-WORD, MS-EXCEL, MS-Powerpoint, Analytical Chemistry, Chemistry, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice.
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Preference will be given to candidates with direct relevant experience in GLP bioanalytical chemistry. Preference will be giving to individuals who have experience in a regulated setting (FDA, GLP, ICH, etc.
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Review toxicology protocols along with reviewing non-clinical protocols for completeness and compliance with FDA current Good Laboratory Practice (GLP) and applicable regulations. Working knowledge of GLP regulations, ICH, and other regulatory guidance documents, and experience conducting and monitoring toxicology studies is critical.
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QPS, LLC is an innovative and dynamic Contract Research Organization (CRO) that has been assisting pharmaceutical, biotechnology, and medical device companies with their drug development efforts by providing a full range of GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services since 1995.
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