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Quality Assurance Specialist

2 months ago

Montgomery County, United States National Institutes Of Health Full time

As a GS-1910-12 Quality Assurance Specialist your duties may include but are not limited to the following:
Assisting with the development and implementation of a Quality Systems approach to manufacturing that is compliant with the FDA's Drug Manufacturing Inspection Compliance Program which includes the Quality System and 5 manufacturing systems: Production System, Facilities and Equipment System, Laboratory Controls System, Materials System, Packaging and Labeling System and Quality System. Implements and monitors the CCE and DTM quality management program that promotes process excellence and is based on the Quality System Essentials (QSE) approach.
Leading quality improvement processes based on best practices; identifying opportunities for improvement and providing leadership with the initiation and implementation of projects to improve facility processes and meet customer needs.
Reviewing and identifying compliance gaps for revised FDA cGMP and cGTP guidelines and communications for changes to federal regulations and current guidance for compliance for blood product manufacturing about, but not limited to, blood product manufacturing including donor eligibility and testing for transmissible disease, human cells and tissues, donor eligibility determination and testing human cells and tissues for transmissible disease.
Reviewing and identifying compliance gaps for compliance with new or modified AABB accreditation standards and NIH -CC and DTM policies and procedures for blood product manufacturing and human cells and tissues collections that include testing for risk of transmission of communicable disease.
Drafting quality objectives with specific measurable activities and processes and quality assurance plans, as needed, for services performed.