Quality Compliance Specialist (Remote) - Regulatory & Data

Cardinal Health; Honolulu (HI); Remote; USD 38,000 - 48,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

Health savings account

401k savings plan

MyFlexPay access

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Specialist, Quality Compliance to help develop and deploy quality policies and programs ensuring regulatory compliance and supply chain integrity. The role involves supporting field actions, regulatory submissions, and data analysis under supervision.

Responsibilities include maintaining GDP compliance, preparing documentation for inspections, and collaborating with senior staff on process improvements.

Qualifications

• 0-2 years of experience, preferred.
• Bachelor's degree in related field, or equivalent work experience, preferred.

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 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.

Education

Bachelor's degree

Job description

Cardinal Health is seeking a Specialist, Quality Compliance to help develop and deploy quality policies and programs ensuring regulatory compliance and supply chain integrity. The role involves supporting field actions, regulatory submissions, and data analysis under supervision.

Responsibilities include maintaining GDP compliance, preparing documentation for inspections, and collaborating with senior staff on process improvements.