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Top 3-5 skills: familiar with US FDA CFRs, regulatory guidance, and cGMPs; prior experience in an audit, compliance or investigation/CAPA role; experience with the following quality systems: risk management, change management; prior experience in a quality assurance role in a biologics manufacturing operation, or similar; could also have prior role in training/learning & performance within Quality; problem-solving techniques for root cause analysis in investigations.
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Speed, accuracy in production assembly, and implementing robust quality assurance processes to. scheduling production to meet daily requirements, overseeing kitting process, runners, ensuring quality.
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Your field duties will include the following: supervision and performance of construction quality assurance and construction quality control activities in several states, including the construction of landfill components and other environmental control systems; collaboration and coordination with senior staff and management and direction of support staff.
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The Senior Manager of Drug Safety & Pharmacovigilance (PV) Quality, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Quality Assurance department.
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This is a full-time position with the responsibility of performing Construction Quality Assurance (CQA) services to observe, document and monitor construction activities associated with landfill construction.
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As a Quality Management System Analyst, you will work closely with our Quality Assurance Manager to assess, analyze, and improve our business processes in accordance with ISO standards.
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The Quality Assurance Specialist will be responsible for supporting oversight of manufacturing, testing and supply chain operations to ensure compliance with current GMP regulations and the Novartis SOP's and systems.
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The Senior Assistant Director works closely with the Office of the University Registrar to manage administrative functions, overseeing systems changes, solving system problems, assisting users with systems issues, acting as liaison between Office of the Registrar (OUR) and IS&T. This position develops applications based on business requirements and testing them for quality assurance.
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The Quality Assurance Review Center (QARC) is a QA and data center within UMass Chan Medical School, Department of Radiation Oncology. Provide overall direction to the division of data management, which may consist of project directors, study managers, research coordinators, and research assistants, for the development of study related materials such as clinical protocol, data management plans, radiation therapy quality assurance manuals, eCRFs, radiation therapy guidelines, etc.
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As we continue to grow, we are seeking a tented Quality Assurance (QA) Specialist to join our team and contribute to the success of our product. As a QA Specialist, you will be responsible for creating and maintaining comprehensive documentation that outlines quality assurance processes, procedures, and best practices.
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Our client, a global healthcare leader whose portfolio of life-changing technologies spans the spectrum of healthcare, is looking for a Quality Assurance Specialist to join their growing team.
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Assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities. Assists in the scheduling and maintenance of Quality Assurance activities and systems.
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The Safety, Environmental & Quality Facilitator is responsible for daily quality control, product testing, and customer quality assurance activities. Facilitate and maintain corporate quality and Environmental, Health and Safety (EHS) systems process and procedures at the plant level.
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The QA Compliance Specialist is responsible for maintaining and/or managing quality systems, processes, and documentation to ensure compliance with current Good Manufacturing Practices (cGMPs.
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The position requires sustained, concise communication with departmental team leaders, project managers, Quality Assurance, and CMC Regulatory Affairs so a firm command of the English language as well as excellent verbal and written communication skills, and a knowledge of computer applications and data acquisition systems are essential.
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