Quality Assurance Specialist

3 days ago


New Hope, Pennsylvania, United States Excellis Health Full time
Excellis Health Solutions: A Global Leader in Strategic Management Consulting

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 Summary

We 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.
Qualifications and Education
  • 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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