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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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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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ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events.
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Full ownership and accountability for all 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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8 years of GMP quality assurance experience in the pharmaceutical, biologics or health industry as Quality Assurance Manager, Lead, Specialist or similar role; 10 years of GMP quality assurance experience in the pharmaceutical, biologics or health industry as Quality Assurance Manager, Lead, Specialist or similar role;OR.
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Our client, a major academic medical center in Boston and the nation's largest hospital based research program, is looking for a Quality Assurance Coordinator to join a major study group dedicated to the further research and care of cardiovascular disease patients.
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The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
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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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The essential function of this role is to provide a high level of customer service, continuous process improvement, strategic planning, cross‐functional support and guidance, and operational/technical assistance to the internal departments and Alzheon’s partners supported by Quality Assurance.
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The Quality Assurance Manager will develop quality assurance plans for the MBTA Call Center by identifying critical issues and preventive measures; establishing monitoring procedures, corrective actions, verification procedures; and monitoring the intake of customer feedback.
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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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HRV Conformance Verification Associates, Inc. supplies a highly integrated series of professional engineering and quality assurance/quality control services worldwide that span the steel, concrete, paint, mechanical, and construction industries.
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ABOUT THE ROLE 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.
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5 or more years of relevant test and quality assurance experience with 3 years’ experience in system and subsystem testing. Manage testing efforts required to deliver the highest quality to the customer.
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quality assurance jobs Title: quality assurance representative in Cambridge, MA
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