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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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GENEWIZ is a leading global genomics service company and trusted provider for DNA sequencing, gene synthesis, molecular biology, next generation sequencing, bioinformatics, and GLP regulatory services.
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Familiar with regulatory standards and quality systems (e.g., GLP, GMP). Extensive hands-on experience in a wide range of analytical techniques, such as UV-Vis, HPLC, CE, SDS-PAGE, icIEF, LCMS, GCMS, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, etc.
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Certified Group includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc., Advanced Botanical Consulting & Testing (ABC Testing Inc.), Microconsult Inc., and Micro Quality Labs Inc. Certified Group provides laboratory testing and regulatory consulting services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, tobacco, nicotine, cannabis, hemp, and other industries.
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Will also be responsible for development and execution of CQV deliverables through formal assessment, protocol development, testing, and reporting in compliance with Charles River Laboratories and all applicable regulatory requirements.
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The Animal Facility Compliance Manager is responsible for ensuring the smooth operation and adherence to regulatory standards at our In Vivo Primate Quarantine and Breeding Facility. - Lead and manage the IACUC to ensure ethical and regulatory compliance in animal care and research.
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Data Management and Compliance: Lead data management planning and ensure adherence to regulatory standards like IRB, HIPAA, GLP, GCP, and FERPA. Evaluation and Reporting: Collaborate with the Senior Director to evaluate the Research Technology Core's effectiveness through detailed reports and data analysis.
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Three (3) years experience working in a regulatory environment or position (GLP, GCP or GMP), a plus. 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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Familiarity with GLP, OSHA guidelines, FDA, BAM, APHA, ISO, and USP methods and procedures. Certified Group is a leading North American provider of laboratory testing, regulatory consulting, and certification & audit services.
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The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
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Lead and manage the Pre-Clinical QA external vendor audit program for all outsourced regulated GLP toxicology, nonclinical and clinical bioanalytical, and clinical laboratories. Ensure regulated internal bioanalytical laboratories and associated functions (toxicokinetic and pharmacokinetic) meet all GLP requirements for nonclinical and clinical study sample analyses.
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The GLP Quality Control Specialist will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all laboratory practices adhere to relevant regulatory requirements.
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The candidate is also expected to support outsourcing efforts for designing, monitoring, execution and reporting of the nonclinical toxicology studies, have experience in managing regulatory-compliant toxicology studies in a CRO or biotechnology/pharmaceutical company, and have demonstrated understanding of GLP compliance and the relevant ICH & FDA guidance documents.
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Contribute as local SME to the design, execution and interpretation of preclinical safety, biocompatibility, analytical chemistry, and toxicological evaluation strategies and programs according to relevant regulatory requirements; including review of literature and assessment of compliance.
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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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