Principal Specialist, Quality Assurance

2 days ago


Nashville, Tennessee, United States Cardinal Health Full time
Job Summary

We are seeking a highly skilled Principal Specialist, Quality Assurance to join our team at Cardinal Health. As a key member of our Quality Assurance department, you will be responsible for developing and implementing quality policies, procedures, and processes to ensure our products and services comply with regulatory standards and specifications.

Key Responsibilities
  • Develop and implement quality policies, procedures, and processes to ensure compliance with regulatory standards and specifications.
  • Provide advice, guidance, and training to PET personnel on various documents and change controls.
  • Interact with Sponsors and Project Managers to ensure needs are met.
  • Develop and implement procedures/protocols for training, document control, and change control as it relates to the Sponsor.
  • Evaluate all document change requests to determine any potential Sponsor impact.
  • Support the technology transfer of Sponsor drug products to Cardinal Health by leveraging compliance, quality, and training to ensure smooth transitions.
  • Collaborate with others to meet deadlines and stay compliant per Sponsor NDA's/IND's.
  • Interact with regulatory agencies and/or sponsor visits as necessary.
Requirements
  • Bachelor's degree in a related field or equivalent work experience.
  • 4+ years of experience in a related field.
  • Experience working with Contract Manufacturers (CMO).
  • PET Quality Experience preferred.
  • Understanding of Quality Agreements preferred.
  • 50% travel required.
What We Offer
  • Competitive salary range: $79,700-$113,800.
  • Bonus eligible: No.
  • Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.


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