Specialist, Quality Compliance

Cardinal Health

1d•$27 - $35

About The Position

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Compliance develops and deploys policies, procedures, and programs designed to minimize risk, enable compliant business operations, products, and services, and maintain supply chain integrity. The Specialist, Quality Compliance supports these policies, procedures, and programs. The role involves routine tasks and projects of limited scope and complexity, with direct supervision and detailed instructions. The Specialist develops competence through structured work assignments and seeks guidance from senior team members, partnering with them on complex projects to build regulatory knowledge and technical capabilities.

Requirements

0–2 years of experience preferred.
Bachelor’s degree in a related field or equivalent work experience preferred.

Responsibilities

Prepare, compile, and coordinate regulatory reports and submissions for internal review and approval in support of field action activities.
Support quality and compliance program implementation by monitoring adherence to procedures, policies, and applicable regulatory requirements and providing guidance to internal stakeholders as needed.
Collect, analyze, and summarize quality and compliance data for regulatory inquiries, inspections, management reviews, and continuous improvement initiatives.
Control, retain, and archive documentation supporting field action activities, ensuring its quality.
Promote and support adherence to Good Documentation Practices (GDP) and data integrity requirements across quality and compliance activities.
Assist in preparing for and executing regulatory inspections and audits.
Partner with senior team members on regulatory submissions, compliance activities, process improvements, and investigations to develop knowledge of applicable regulations and internal quality requirements.