Senior Quality Assurance Specialist - Compliance & Audits

Regulatory Jobs; Aurora (CO); Sur place; USD 69 000 - 88 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Employee assistance programs

Paid parental leave

Résumé du poste

Cardinal Health is seeking a Senior Specialist, Quality Assurance to execute quality programs and support the Manager, Quality Assurance in audits and SOP development. This role focuses on recalls, customer complaints, and compliance with regulatory standards to minimize risk and sustain supply chain integrity.

With 2-4 years of experience and a Bachelor's degree, you will mentor junior specialists and contribute to SOP updates while partnering with stakeholders to drive quality improvements.

Qualifications

• 2-4 years of experience preferred.
• Bachelor's degree in related field, or equivalent work experience, preferred.

Responsabilités

• Ensures fulfillment of external reporting requirements related to recalls and submits reports for internal review.
• Executes internal programs to define Quality guidelines and track adherence.
• Responds to significant quality issues and conducts root cause analyses with the Manager to inform metrics and trends.
• Supports the Change Control Program by assessing QA implications of changes.
• Updates SOPs in response to product changes and regulatory developments.
• Prepares responses to regulatory queries, audits, and internal audits.
• Supports internal QA audits and inspections and documents findings for stakeholders.
• Guides junior staff and assists with onboarding trainings.

Connaissances

Quality Assurance

Regulatory compliance

Formation

Bachelor's degree

Description du poste

Cardinal Health is seeking a Senior Specialist, Quality Assurance to execute quality programs and support the Manager, Quality Assurance in audits and SOP development. This role focuses on recalls, customer complaints, and compliance with regulatory standards to minimize risk and sustain supply chain integrity.

With 2-4 years of experience and a Bachelor's degree, you will mentor junior specialists and contribute to SOP updates while partnering with stakeholders to drive quality improvements.