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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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Conduct quality assessments of GMP, GCP and GLP Vendors systems. The Manager Quality Systems will further develop and maintain the quality management systems supporting clinical trial activities within PepGen. Routine activities include development and maintenance of supplier management programs, including qualification assessments, auditing, quality agreements, and supplier list.
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Demonstrates effective use of computer-based information andpractice management systems for population health management, decision support, reports relative to the provision of care, continuous quality improvement and professional development.
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Minimum 10 years in quality assurance management and compliance, ideally with cell therapy/viral quality systems, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
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Systems include but not limited to EPIC, Optility and PET Manager. 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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QualificationsQualifications: ·An advanced degree (Masters) in healthcare administration, health services research, health policy, information systems, business or other relevant fields is preferred.
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Responsible for 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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The MassHealth Systems Teams unit seeks a highly motivated individual as a Quality Assurance Tester to join its Data Warehouse Systems Quality Assurance (SQA) team. The Quality Assurance Tester will be responsible for working on complex projects within the Healthcare Domain and applying knowledge of software testing and analysis concepts, practices, and procedures.
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The Role We Want You ForAs an MEP Superintendent, you will be based on the construction project site and will be responsible for field operations and onsite construction management of design-build construction projects, specifically quality control for mechanical, electrical, plumbing, and fire protection, construction, start up, and testing on highly complex projects nationwide.
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Define and implement global Sales and Operations Planning (S&OP) and External Supply Chain key supply chain business practices and systems to ensure alignment and deliver exceptional service and transparency to key internal and external partners including Manufacturing, Quality, Commercial, and Finance.
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Design and oversee the implementation of quality systems specifically for CMC development activities, including the release of products for GLP and GCP studies. Identify and drive improvements in quality processes and systems to enhance overall product quality and compliance.
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This role requires a deep understanding of both the business and IT aspects of Quality Management Systems (QMS), particularly in migrating data from TrackWise to Veeva QMS. The SME will play a critical role in responding to RFPs with technical approaches, crafting solution proposals, and leading significant implementation projects.
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Utilize Quality improvement principles, systems, tools, and skills needed to drive progress. Applicants must have at least (A) five (5) years of full-time or, equivalent part-time, professional, professional internship, administrative, supervisory, or managerial experience in business administration, business management, public administration, public management, clinical administration or clinical management Knowledge of effective public health strategies that address social determinants of health, including those that address health, racial equity related to systems of oppression.
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Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions (USA, UK & EU), understanding of 21CFR Pt. 11 with respect to clinical systems (QMS). Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate.
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Maximize reporting, analytics and dashboards via core business systems, to include, but not limited to: Epic Systems, Workday and Strata Jazz. The Analytics manager should be proactive in approach by meeting leaders data needs through reporting deployed through core business systems: Epic, Workday and Strata Jazz.
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systems quality jobs in Quincy, MA
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