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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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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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Executes quality assurance reviews of core audit activities i.e. audits, issues validation, audit plan documentation and coverage, and other special projects, using predefined attributes and challenge questions, relevant for the review type and in accordance with the QA strategy.
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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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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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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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Ongoing supervision and education of Nutrition Assistant staff through review and co-signing charts for purposes of Quality Assurance required by Federal/State standards. Assists Senior Nutritionist with training of the paraprofessional Nutrition Assistant staff in completion of required activities and performance skills necessary to achieve CPAI or CPAII status.
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The Associate Director, Lab Operations Quality Assurance, will work as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications.
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Oversee quality assurance activities to ensure the integrity, accuracy, and compliance of clinical trial data within Veeva Vault applications, in accordance with regulatory requirements (e.g., FDA guidelines, GCP standards.
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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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Must have experience with Day Hap (MA Health) system and DDS (HICSIS) Quality Assurance Provide input in programs and preparation for CARF, DDS survey and annual DMA audits. About the Job: Job responsibilities : To assure the highest quality of services to the people in our day habilitation programs.
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Scope of ResponsibilityWill serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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Ensure compliance regulatory compliance with respective contract and model fidelity in conjunction with program leadership and Quality Assurance Team and VP of Homeless Services including State and Federal outcomes reports, third party billing, and HMIS data collection and reporting.
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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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quality assurance jobs Title: assurance assistant in Waltham, MA
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