Specialist, Quality Compliance
Cardinal Health
United States0–2 yrs52m agovia LinkedIn
About the Role
The Specialist, Quality Compliance supports the development and deployment of policies, procedures, and programs designed to minimize risk, enable compliant business operations, products, and services, and drive uncompromised supply chain integrity.
Key Responsibilities
- Supports field action activities by preparing, compiling, and coordinating required regulatory reports and submissions for internal review and approval.
- Supports implementation of quality and compliance programs by monitoring adherence to established procedures, policies, and applicable regulatory requirements, and providing guidance to internal stakeholders.
- Collects, analyzes, and summarizes quality and compliance data to support regulatory inquiries, inspections, management review activities, and continuous improvement initiatives.
- Handles and ensures quality of documentation (control, retention, and archival) to support field action activities.
- Promotes and supports adherence to Good Documentation Practices (GDP) and data integrity requirements across quality and compliance activities.
- Assists in the preparation for and execution of regulatory inspections and audits.
- Partners with senior team members on regulatory submissions, compliance activities, process improvements, and investigations to develop knowledge and process of applicable regulations and internal quality requirements.
Requirements & Tech Stack
- The Specialist frequently seeks guidance from more experienced senior team members and assists on more complex projects.
- Applies basic concepts, principles, and technical capabilities to perform routine tasks.
- Works on projects of limited scope and complexity.
- Follows established procedures to resolve readily identifiable technical problems.
- Works under direct supervision and receives detailed instructions.
- Develops competence by performing structured work assignments.
Qualifications
- Bachelor's degree in a related field, or equivalent work experience.
- 0-2 years of experience is preferred.