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Reporting to the COO, The Vice President, GxP Quality Assurance is responsible for establishing and leading Aveo's Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems in a fast-paced, primarily virtual development environment.
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The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing.
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All breast imaging technologist positions include the responsibility of the delivery of safe and effective imaging procedures, participation in departmental education programs, participation in organizational and departmental goals and priorities and active involvement in Quality Assurance/Quality Improvement (QA/QI) activities.
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Manage, onboard, and lead the General Contractor BMS Lead(s), the Control Systems Integrator (CSI) and Electrical and Installation (E&I) controls contractor throughout all phases of the project, while developing program efficiency improvements and incorporating lessons learned to ensure a safe, robust, reliable and functional controls system that adheres to Facebook's design and quality requirements.
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The Quality Assurance Analyst (“QA Analyst”) will be primarily responsible for systematically testing both new and existing functionality, identifying issues, troubleshooting, and putting forth recommended solutions.
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Working under the supervision of Harvard Faculty Directors, the Echo Tech II will be an integral member of the CICL and will assist with high-level, complex research including but not limited to echocardiographic analysis and data quality assurance.
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Experience in apheresis, cell therapy/stem cell transplantation, bone marrow transplant, hem/onc, laboratory medicine, and/or regulatory compliance/quality assurance preferred. Join our team at Massachusetts General Hospital (MGH) as an Apheresis Quality Specialist and play a crucial role in maintaining the integrity of our Apheresis unit.
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Represent the Quality Assurance Validation group in project teams, audits, and inspections. Provide quality guidance on process qualification, and continuous process verification strategies for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally and at CMOs.
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Broad industry experience and technical background across GxP encompassing Production, Quality Assurance, Clinical Development and Quality Control. Lead the organization’s ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production.
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Coordination with other Vertex groups (such as Analytical Development, Materials Discovery and Characterization, Supply Chain Management, Quality Assurance, etc.) The Formulation Research Scientist will work with other scientists dedicated to advancing drug candidates from exploratory development through commercial line extension in a Quality by Design (QbD) environment using lab based and computational tools to design and select dosage forms and manufacturing process.
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Experience developing quality control plans, supplier quality audits, failure analysis, and root cause corrective actions. 2 or more years of related experience in Manufacturing and/or Quality Engineering.
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Role, you will use existing SOPs and quality assurance standards to monitor, observe, and record animal health and welfare daily, as well as complete various standard animal husbandry duties.
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Reporting to the Assistant Clinical Director (ACD) of X-Ray, the Quality Assurance (QA) Specialist facilitates the X-Ray QA program and provides appropriate education and guidance to staff which includes assessing, planning, implementing, and evaluating both orientation and continuing education programs to enhance the quality of patient care services.
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The Director of Construction Quality Assurance leads the City's efforts to ensure that all new buildings and major renovations are built to and perform at the highest level. The Director conducts design review, onsite education, inspection, and enforcement and promotes a quality mindset across the various building disciplines.
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Leads the global Clinical, Pharmacovigilance, and Medical Quality Compliance organization, providing quality oversight of the quality systems supporting Takeda’s clinical research (GCP), pharmacovigilance (GVP) and medical activities across the enterprise and ensuring that it’s robust, aligned with and compliant to applicable regulatory requirements, and governed and positioned for continual improvement.
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quality assurance jobs Title: assurance assistant in Boston, MA
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