Quality Assurance Specialist

3 days ago


New Hope, Pennsylvania, United States Excellis Health Full time
Job Overview

Excellis Health Solutions, LLC, a global strategic management consulting services firm, is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for providing quality expertise to both our staff and external clients.

Key Responsibilities:

  • Interpret and apply current regulations, including FDA regulations for Pharmaceutical and Medical Device products, to ensure compliance with quality standards.
  • Conduct internal and external audits to evaluate the degree of quality compliance and conformance to regulatory requirements.
  • Develop and recommend Corrective Action Preventive Action (CAPA) activities to address quality issues.
  • Support the implementation of Quality Management Systems (QMS) and monitor risk management activities.
  • Collaborate with project teams to ensure compliance requirements are understood and addressed in project deliverables.

Requirements:

  • Proven experience in pharmaceutical and medical device regulatory affairs within the FDA regulated industry.
  • Knowledge of DSCSA regulations for prescription pharmaceutical products and product launch regulations.
  • Self-starter with the ability to work independently on a project-by-project basis.
  • BS degree or higher in a relevant field.


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