Quality Assurance Specialist
3 days ago
Excellis Health Solutions, LLC, an NNIT Group Company, is a global strategic management consulting services firm with a strong presence in the pharmaceutical and life sciences industry. Our team of experts provides comprehensive solutions to clients, leveraging our extensive knowledge and proven track record of success.
Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for providing quality expertise to both our staff and external clients. Your primary focus will be on ensuring regulatory compliance, interpreting and overseeing quality compliance aspects of regulations, and providing expert input to those responsible for assuring compliance.
Key Responsibilities- Interpret and apply FDA regulations for pharmaceutical and medical device products, including those related to development, manufacturing, labeling, packaging, testing, storing, and distributing products.
- Understand and interpret DSCSA regulations for pharmaceutical prescription products across the entire supply chain.
- Conduct internal and external audits to evaluate quality compliance and conformance to regulatory requirements and organizational QMS.
- Develop and recommend CAPA activities, evaluate QA procedures and policies, and support implementation of QMS.
- Monitor risk management activities and work with project teams to ensure compliance requirements are understood and addressed.
- Prior experience in pharmaceutical and medical device regulatory affairs within the FDA regulated industry.
- Experience with DSCSA regulations for prescription pharmaceutical products and product launch regulations.
- Prior quality compliance experience within the FDA regulated industry, including conducting audits.
- Self-starter with the ability to work independently on a project-by-project basis.
- BS degree or higher.
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Quality Assurance Specialist
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Quality Assurance Specialist
1 week ago
New Kensington, Pennsylvania, United States Synerfac Full timeJob Title: Quality Assurance SpecialistJob Summary:We are seeking a skilled Quality Assurance Specialist to join our team at Synerfac. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes. This role requires a strong attention to detail, excellent analytical skills, and the ability to work...
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Quality Assurance Document Controller
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Quality Assurance Supervisor
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Document Control Specialist
4 weeks ago
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Quality Assurance Specialist
4 days ago
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Quality Assurance Specialist
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Quality Management System Administrator
4 weeks ago
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Quality Assurance Supervisor
3 weeks ago
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Manufacturing Quality Assurance Specialist
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4 weeks ago
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Culinary Support Specialist
4 weeks ago
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Quality Control Specialist
2 weeks ago
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Document Control Specialist
4 days ago
New Hope, Pennsylvania, United States ORCHESTRA BIOMED, INC. Full timeAbout Orchestra BioMedOrchestra BioMed is a pioneering biomedical innovation company that accelerates high-impact technologies to patients through strategic partnerships with leading medical device companies. Our vision is to revolutionize medical innovation by forging collaborative relationships with industry leaders to drive successful global...
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Document Control Specialist
4 weeks ago
New Hope, Pennsylvania, United States Orchestra BioMed Full timeAbout the RoleOrchestra BioMed is seeking a highly skilled Document Control Specialist to join our team in New Hope, PA or Ft. Lauderdale, FL. As a key member of our Quality Management System team, you will be responsible for managing and maintaining our company's documentation to ensure compliance with regulatory standards for medical devices.Key...
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Food Safety and Quality Control Specialist
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