Job Postings- Liminal R&D BioSciences Inc. (LBRD)

QA Specialist

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Prometic Group Employee Handbook Quality Assurance Specialist 1 At Prometic, over 450 people work at saving lives, one role at a time. Located at the heart of the City of Rockville, MD, our Prometic Biotherapeutics Inc. division is blooming as we are currently developing a treatment for orphan diseases affecting children, made of plasma-derived proteins. Our treatment will allow these children to have a new pathway to hope. To contribute to this revolutionary and innovative project, we are looking for a QA Specialist to provide support to the QA department to assist with documentation, archival and maintenance of QA studies. Scans, maintains various data bases for QA tracking. Maintains QA operations file. Reviews QA data files for purposes of archiving. Coordinates the Quality Assurance (QA) policies and procedures in a work environment to ensure quality and regulatory standards are being followed. The QA Specialist will contribute to the team by: • Review and approval of analytical methods testing. • Maintain document tracking system as assigned for all QA documents, including but not limited to scanning of documentation into the system. • Assist in off-site archiving of documentation for all PBT documents. • Perform Monthly internal audit/reviews • Assist with review of submitted SOP's for approval • Review documentation for vendor qualification forms submitted • Assist with the document control for all GMP related activities and clinical program. This involves SOP versioning and tracking, formatting, review and routing for signatures. • Oversee all new hire GMP training requirements as well as monitoring and maintaining all GMP training records. You are the right person for this role because: • You hold a Bachelor Degree in Science, preferred • You have A minimum of 2 years of experience in an administrative position related to Quality Assurance • Some knowledge and understanding of GMP, as well as experience with GLPs regulations and guidelines. Job Opportunity Quality Assurance Specialist

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