Principal Specialist, Quality Assurance

About the Role

The Principal Specialist, Quality Assurance is responsible for reviewing all customer threshold activity requests for controlled substances in compliance with set standards. This role reviews inbound requests, assesses them for risk, and escalates according to standard operating procedures. The Principal Specialist assists the Manager, Regulatory Management in data entry activity and documentation drafting/filing, ensuring consistent application of threshold methodologies across the organization.

Responsibilities

• Assists Quality Management with FDA and other regulatory agency activities.
• Documents and reports 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.
• Canvasses order volume reports and publicly available data to identify suspicious activity and determine sites of interest.
• 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.

Qualifications

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

Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects. May contribute to the development of policies and procedures. Works on complex projects of large scope and develops technical solutions to a wide range of difficult problems. Completes work independently; receives general guidance on new projects. Work is reviewed for purpose of meeting objectives. May act as a mentor to less experienced colleagues.

Pay

Anticipated salary range: $80,900.00–$103,950.00.

Benefits

• Medical, dental, and vision coverage.
• Paid time off plan.
• Health savings account (HSA).
• 401k savings plan.
• Access to wages before payday with myFlexPay.
• Flexible spending accounts (FSAs).
• Short- and long-term disability coverage.
• Work-life resources.
• Paid parental leave.
• Healthy lifestyle programs.