Quality Assurance Specialist
1 week ago
Join the National Institutes of Health as a Quality Assurance Specialist and contribute to ensuring the safety, quality, and effectiveness of services and activities within the organization.
Job SummaryThe Quality Assurance Specialist will be responsible for administering the Quality Assessment/Improvement (QA/I) program, ensuring compliance with regulatory agency requirements, and implementing quality management systems. The ideal candidate will have experience in quality assurance, regulatory compliance, and quality management, with a strong understanding of FDA cGMP and cGTP guidelines.
Key Responsibilities- Develop and implement quality systems approaches to manufacturing, ensuring compliance with FDA regulations.
- Administer the QA/I program, including process control, document control, equipment validation, and systems monitoring.
- Review and ensure compliance with FDA cGMP and cGTP guidelines, as well as AABB and NIH policies and procedures.
- Collaborate with cross-functional teams to implement quality management systems and ensure process excellence.
- Conduct quality audits and review audit findings, implementing corrective and preventive actions as needed.
To be eligible for this position, candidates must have at least one year of qualifying experience equivalent to the GS-11 level in the Federal Government, performing tasks such as quality assurance, inspection, and quality management. The ideal candidate will have a strong understanding of quality systems, regulatory compliance, and quality management, with experience in aseptic processing and cGMP facilities.
What We OfferThe National Institutes of Health offers a comprehensive benefits package, including health insurance, retirement plans, and paid time off. As a Quality Assurance Specialist, you will have the opportunity to work in a dynamic and collaborative environment, contributing to the organization's mission to improve human health.
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