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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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The Software Quality Assurance Testing Engineer will play a key role in the quality assurance of Anti-Money Laundering (“AML”), Sanctions Screening, AML Transaction Monitoring, and Know Your Customer (“KYC”) suite of applications in the Boston, MA area.
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The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
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Assist the BEST Program QA and Test Lead in all aspects of the Software Development Life Cycle (SDLC) methodologies, including executing quality assurance best practices and implementing quality controls.
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2-3 years in a healthcare specialty required; experience in apheresis, cell therapy/ stem cell transplantation, bone marrow transplant, hem/onc, laboratory medicine, and/or regulatory compliance/quality assurance preferred.
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Reporting to the Field Operations Manager, Quality Assurance Inspectors partner with HPC's, residential customers, and Abode office staff to ensure that work completed under the Mass Save program meets program standards, is high quality, and delivers a great customer experience.
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Assist the Program QA and Test Lead in all aspects of the Software Development Life Cycle (SDLC) methodologies, including executing quality assurance best practices and implementing quality controls.
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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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Alternatively 5 years Regulatory CMC experience combined with 5 years relevant vaccines or biologics experience (e.g. Pharmaceutical Development, Process Development, Analytical Development, Production, Quality Assurance.
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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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GMP quality assurance experience in the pharmaceutical or biotechnology industry. The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site.
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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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The Director/Sr. Director, Global GMP Quality has multiple direct reports, is a member of the Quality Assurance Leadership Team (QALT) and reports to the Vice President, Quality Assurance.
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The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
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quality assurance jobs Title: quality assistant Company: Inc in Waltham, MA
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