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Quality Assurance Technician

Company: Alpha Tau Medical
Location: Lawrence
Posted on: May 7, 2022

Job Description:

Alpha Tau Medical focuses on the research, development, and commercialization of Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) to treat solid tumors. Initially developed at Tel Aviv University, Alpha DaRT was effective and safe for treating different types of cancer in multiple animal studies. The company is running its first clinical trial at several sites in the EU and is currently commencing clinical trials at over 55 leading cancer centers worldwide. Main Responsibilities As a Quality Assurance Technician focused on Operations, you will work in a multidisciplinary operational group and provide quality direction for all daily business operations; -- You will identify critical areas for improvement related to manufacturing processes and prioritize and execute quality improvement initiatives resulting from this work. As needed, you will perform or support non-conformance /CAPA root cause investigations, defining action plans, and driving these to completion; -- You will be responsible for inspection readiness of the projects in the scope of your work, and will act as a Subject Matter Expert during internal and external audits (e.g., Notified Body or FDA audits); -- You will be expected to escalate any quality or compliance issues to upper management; -- You will act as the Quality point of contact and decisionmaker during manufacturing and Change Control activities while ensuring that all activities meet internal and regulatory expectations; -- You will analyze manufacturing data for continuous improvement purposes and for reducing or eliminating sources of variation within the production process; -- You will be responsible for reviewing documentation; -- You will be responsible for providing advice on drafting protocols or procedures on a variety of subjects; -- You will perform QC checks along the production chain, from incoming to final, and approved products to be shipped out. Qualifications -- At least 2 years of relevant work experience, preferably in the pharmaceutical or medical device industry; -- At least a relevant bachelor's degree (Technical, Life Science, or related); -- Knowledge of Risk Management; -- Knowledge of validation of products, equipment, and processes; -- Knowledge of statistics; -- Knowledge of relevant regulations (GMP, MDD, QSR CFR 820, ISO 13485, ISO 14971); -- Knowledge of MS Office; -- Communication skills, flexibility, and accuracy; -- Being able to function independently as well as part of a team; Job Type: Full-time Experience: Relevant work: 2 years (Preferred) Education: Bachelor's (Preferred) Work Location: One location Work Benefits: Health insurance Flexible schedule

Keywords: Alpha Tau Medical, Lawrence , Quality Assurance Technician, Professions , Lawrence, Massachusetts

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