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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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Knowledge of laws, regulations, policies and guidelines that govern animal research, research conduct principles (GLP) and current methodology of laboratory animal medicine and management is important.
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Conduct internal audits to assess effectiveness of Entrada's GCP/GLP QMS and process compliance including Clinical Study Report (CSR). Act as GCP subject matter expert within the QA function to enhance the Quality System in accordance with ICH Guideline E6 (R2) Good Clinical Practice (GCPs), 21 CFR part 58 Good Laboratory Practices (GLP), and other global regulatory authority requirements and industry practices.
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Experience in GLP toxicity studies in both small and large animal models. 12 peer reviewed publications in pharmacology, toxicology, or relevant biomedical science discipline. Diplomate of American Board of Toxicology (DABT) required for Sr. Principal Toxicologist.
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Experience in working in regulated environment with quality systems and knowledge of ISO or GLP quality standards a plus. Molecular Biology applications: PCR, cloning, site-directed mutagenesis, RNA extraction, RT-PCR, Sequencing analysis.
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Lead identification of assay requirements, lab selection, and contract development to ensure regulatory compliance according to GLP, GCP, and applicable global regulatory requirements such as CLIA and EU IVDR, and execution feasibility.
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The Principal Toxicologist will work closely with the Nonclinical Study Managers which will help to oversee and manage the outsourced nonclinical studies (non-GLP and GLP). In-depth experience with designing, conducting, and evaluating non-GLP and GLP non-clinical studies within toxicology and/or safety pharmacology, preferably with experience with siRNA/oligonucleotides.
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Full ownership and accountability for all Quality & Controls Assurance programs, activities and reviews, including claims reviews; call center and digital communications reviews; Medicare Risk Adjustment, HCC, clinical and coding reviews; DRG and medical records reviews; technology/systems and coding upgrade and implementation reviews (e.g. final user acceptance testing, etc.
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About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment.
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We are looking for an outstanding Quality Assurance Engineer – Requirements, Test Plans & Reports, who will convert functional requirements into test-plans for the QA Manual Testing team to execute, and summarize learning in Validation Test-reports.
$95,700 - $177,900 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Guarantee the timely completion and high-quality review of DMPK reports, including BA and TK reports from nGLP and GLP toxicology studies., Experience and proficiency in managing activities at CROS as well as managing GLP and regulated activities.
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The team seeks an experienced Senior Optical/Mechanical Designer to drive the design, fabrication, integration, and testing of cutting-edge sensor systems. Design and model mechanical enclosures and optical assemblies, ensuring proper mounting, adjustment, alignment, measurement techniques, precision bearings, gearing, drive systems, structural/thermal analysis, and environmental testing.
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Must be very proficient with the common tools associated with red teaming, penetration testing, and vulnerability assessments (Metasploit, Burp Suite, Cobalt Strike, Kali, etc. This is a highly technical role that requires broad technical knowledge and a deep understanding of threats and threat TTPs. You will lead and participate in advanced technical assessments that leverage red team, penetration testing, and vulnerability assessment tools and techniques to identify hi-risk vulnerabilities across a variety of technologies.
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Understands, conducts, and documents appropriately Dialysis/Apheresis machine safety tests/alarm tests, equipment calibration, dialysate testing, machine safety tests, functional testing, and internal and external disinfection on all water & dialysis machines, and complies with the documentation/notification standards per FMS policies.
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Systems include but are not limited to EPIC, Optility, PET Manager, Syngo, and ·Alerts Unit Technical/Operations Manager regarding equipment problems, problems encountered during testing, etc. ·Follows the instructions of the Authorized User (AU) physician and authorized nuclear pharmacist for the preparation of radiopharmaceuticals and quality control testing.
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glp testing jobs Title: associate Company: Aequor in Woburn, MA
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