Senior Quality Assurance & Compliance Specialist

Cardinal Health, Inc.; Legendary Hills (IN); Presencial; USD 81.000 - 104.000; Jornada completa

Descripción de la vacante

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Assurance to review customer threshold activity requests for controlled substances and ensure compliance with set standards.

You will assess inbound requests for risk and escalate per SOPs, while assisting the Manager, Regulatory Management with data entry and documentation drafting. The role ensures consistent application of threshold methodologies across the organization and may involve on-site visits, mentoring colleagues, and

Formación

• cGMP/compliance knowledge required for cosmetic/pharmaceutical products.
• Strong quality assurance expertise and regulatory awareness.
• Mentorship or coaching abilities a plus.

Responsabilidades

• Assists Quality Management with FDA/regulatory agency activities.
• Document and report quality and compliance issues to QA management.
• Proposes and/or implements audit program enhancements.
• Audits groups to ensure regulatory compliance and consistency.
• Drafts regulatory documents to support risk management.

Conocimientos

cGMP/compliance knowledge

Quality assurance expertise

Mentorship abilities

Educación

Bachelor's degree or equivalent

4-8 years of experience

Descripción del empleo

Cardinal Health, Inc. is seeking a Principal Specialist, Quality Assurance to review customer threshold activity requests for controlled substances and ensure compliance with set standards.

You will assess inbound requests for risk and escalate per SOPs, while assisting the Manager, Regulatory Management with data entry and documentation drafting. The role ensures consistent application of threshold methodologies across the organization and may involve on-site visits, mentoring colleagues, and