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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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About Insourcing SolutionsCharles 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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BS with 5+ years in biopharma Quality Assurance (Extensive experience within GLP or GCP preferred) Job Overview: Our client is looking to add an Associate Director of Quality Systems to support and expand on the quality management systems and processes and be a key stake holder in driving the quality culture including GCP and GLP compliance.
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Oversee, provide and facilitate the day-to-day operations of the vivarium, husbandry and technical staff and act as primary liaison for on-site clients and staff for research needs. Schedule all required vivarium equipment preventative maintenance and calibration.
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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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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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Draft, review, revise or provide input to GCP/GLP/GVP SOPs to assess consistency and compliance with regulatory requirements/internal standards. Attend cross-functional team meetings and provide guidance to GCP/GLP/GVP functional groups based on interpretation of current regulations to ensure best practices including risk-based management.
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Lead investigations into significant quality issues, scientific misconduct and suspected serious breach of GCP or GLP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate.
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Partners with CMC, Clinical Development, Clinical Operations and Pharmacology to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance. Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
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The Associate Director/Senior Manager of Clinical Quality will develop, manage, and improve existing quality systems to ensure appropriate controls for EyePoint in-house GCP and GLP capabilities.
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Provide quality assurance oversight of GCP, GLP, and GMP operations for both internal and external production and use of regulated therapeutics products (ATMPs) Plan and host regulatory inspections, as well as external GxP audits.
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Building on our success in developing the world's first GLP-1 peptide in a tablet, we are rapidly growing our activities in our relentless pursuit of the next generation of oral-based therapies across a range of new modalities.
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Strong knowledge of regulatory requirements and guidelines (e.g., cGMP, GLP, ICH) governing pharmaceutical manufacturing and testing. Job Title: QA/QC Analyst Company : AstraZeneca Overview : The QA/QC Analyst at AstraZeneca is likely responsible for ensuring the quality and compliance of products and processes within the company's pharmaceutical manufacturing or research facilities.
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Working knowledge of regulatory requirements/ standards (e.g., GCP, GLP, CAP, CLIA, NYSDOH, 21 CFR Part 11). ● Serve as the GLP/GCP subject matter expert to cross-functional clinical trial teams to ensure that all quality and regulatory compliance activities were conducted in compliance with GCPs, SOPs, and ICH Guidelines.
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We are looking for a professional with expertise in laboratory quality management systems (GCP, GLP), clinical Bioanalytics (mainly large molecules), pharmacokinetics, standard laboratory requirements, and familiarity with quality & information management systems.
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