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