Quality Compliance Associate: Regulatory Submissions

Cardinal Health, Inc.; United States; Presencial; USD 38.000 - 48.000; Jornada completa

Descripción de la vacante

Cardinal Health is seeking a Specialist, Quality Compliance to support the development and deployment of policies, procedures and programs that minimize risk and ensure compliance across operations. You will work under supervision, contributing to regulatory submissions and improvement efforts while building advanced knowledge in quality systems.

The role involves handling documentation, GDP adherence, and assisting in inspections and audits to help maintain supply chain integrity and regulatory

Formación

• 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.

Responsabilidades

• 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 as needed.
• 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.
• Assist 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.

Educación

Bachelor's degree in related field

Descripción del empleo

Cardinal Health is seeking a Specialist, Quality Compliance to support the development and deployment of policies, procedures and programs that minimize risk and ensure compliance across operations. You will work under supervision, contributing to regulatory submissions and improvement efforts while building advanced knowledge in quality systems.

The role involves handling documentation, GDP adherence, and assisting in inspections and audits to help maintain supply chain integrity and regulatory