What are the responsibilities and job description for the Quality Specialist position at Tellus Solutions?
Tellus Solutions is in partnership with a committed biopharmaceutical company in Worcester focused on providing innovative therapies. Your technical expertise as a Quality Specialist in the area of US FDA CFRs, regulatory guidance, and cGMPs will contribute to our client's innovative therapies which will impact the quality and duration of life.
Job Description:
Skills:
Familiar with US FDA CFRs, regulatory guidance, and cGMPs; prior experience in an audit, compliance or investigation/CAPA role
Experience with the following quality systems: risk management, change management; prior experience in a quality assurance role in a biologics manufacturing operation, or similar
Could also have prior role in training/learning & performance within Quality
Problem-solving techniques for root cause analysis in investigations.
Document reviewer and change management record owner with 5 years of experience in document ownership, review and revision as well as change management that goes along with that role.
Education:
Bachelor's degree in Science or Engineering
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