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Quality Assurance Lead for the cross-functional CMC Sub-Teams. The Director, CMC QA will report to the Executive Director of CMC QA and be responsible for maintaining strategic responsibility over QA Operations, developing and implementing Ultragenyx CMC Quality approach for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality.
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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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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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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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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 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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Five years minimum experience in the clinical laboratory or biotechnology with strong background in blood bank/hematology and marrow/stem cell manufacturing and experience and/or extensive knowledge in quality assurance/improvement, regulations and compliance.
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Currently possess or the ability to attain; NETTCP Quality Assurance Technologist, and USACE Construction Quality Manager Certification. Minimum of five (5) years of documented experience performing in a construction quality control management role on a heavy civil construction project.
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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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Certification as an energy code compliance professional (e.g., Certified Energy Plans Examiner, Certified Energy Inspector). ISD ensures that new building construction and major renovations are energy efficient, reduce greenhouse gas emissions, prepare for and adapt to the effects of climate change, and support best practices for overall environmental performance.
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The Good Clinical Practice (GCP) Senior Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are conducted ethically, with integrity, and in compliance with regulatory requirements and GCP guidelines.
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Must have strong knowledge of biologics and small molecules manufacturing, materials management, quality control, quality assurance and CMC regulatory requirements. The position is responsible for product development, technology transfer and overall management of CMC activities related to ensuring robust development and reliable GMP supply of oligonucleotide conjugates and intermediates.
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The Quality Assurance Lead will play a critical role in ensuring the highest quality of our under-development video game. A minimum of 5 years of experience in quality assurance for PC or console video games, with at least 2 years in a leadership role.
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You will report to the Executive Director, Quality Assurance at Ultragenyx Gene Therapy. As the Director, Quality Assurance Warehouse Operations you be responsible for QA oversite of the warehouse and supply chain production processes at the new gene therapy manufacturing facility located in Bedford, MA. During the construction and qualification phases this will be a critical role in establishing the quality oversight for processes such as material receipt, material release, and material management while interfacing with the ERP system.
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quality assurance jobs Title: quality assurance assistant in Waltham, MA
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