Strategic QA Specialist: Regulatory Compliance & Thresholds

Cardinal Health; Indianapolis (IN); On-site; USD 81,000 - 104,000; Full time

Benefits offered by this job

Medical coverage

Paid time off

Health savings account

401k savings plan

MyFlexPay access to wages

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health seeks a Principal Specialist in Quality Assurance to review customer threshold activity requests for controlled substances, assess risk, and support regulatory documentation. This role assists the Manager in data entry and filing, ensuring consistent application of threshold methodologies across the organization.

Key responsibilities include supporting FDA/regulatory activities, auditing for compliance, and mentoring staff. Salary range is anticipated and bonus eligibility is No.

Qualifications

• Bachelor's degree in related field, or equivalent work experience, preferred.
• 4-8 years of experience, preferred.
• Possess an understanding of cGMP/compliance requirements for cosmetic or pharmaceutical products.
• CQA preferred

Responsibilities

• Assists Quality Management with FDA and other regulatory agency activities.
• Document and report quality and compliance issues to QA management as necessary.
• Proposes and/or implements audit program enhancements.
• Audits groups to ensure consistency in the application of practices and regulatory compliance with established methodologies.
• Completes work independently; receives general guidance on new projects.
• Drafts memos and other regulatory related documents to support risk management activities.
• May act as a mentor to less experienced colleagues.
• Coordinates on site visits to ensure successful completion of investigations ensuring necessary staff will be on site at the time of the visit.
• Prepares Cardinal Health communications relating to site visits and related investigatory activity.
• Prepares investigators for site visits through the collection and distribution of investigation materials.
• Canvases order volume reports and publicly available data to identify suspicious activity and determine sites of interests.
• Reviews threshold events triggered by customer orders nearing or exceeding predetermined thresholds.
• Approves and implements threshold adjustments and requests within certain controlled substance levels.
• Escalates threshold events for management review and approval, as needed.
• Ensures compliance with established memorandums of agreement.
• Drafts memos and other regulatory related documents to support risk management activities.

Skills

4-8 years experience

cGMP knowledge

Regulatory compliance

Quality assurance

Education

Bachelor's degree in related field

Job description

Cardinal Health seeks a Principal Specialist in Quality Assurance to review customer threshold activity requests for controlled substances, assess risk, and support regulatory documentation. This role assists the Manager in data entry and filing, ensuring consistent application of threshold methodologies across the organization.

Key responsibilities include supporting FDA/regulatory activities, auditing for compliance, and mentoring staff. Salary range is anticipated and bonus eligibility is No.