Principal Specialist, Quality Assurance

Cardinal Health•Indianapolis, IN

20h

About The Position

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. The Principal Specialist, Quality Assurance is responsible for reviewing all customer threshold activity requests for controlled substances in compliance with set standards. This job reviews inbound requests, assesses them for risk and escalates according the standard operating procedures. The Principal Specialist, Quality Assurance assists the Manager, Regulatory Management in data entry activity and documentation drafting/filing. This job ensures the consistent application of set threshold methodologies across the organization.

Requirements

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
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
Develops technical solutions to a wide range of difficult problems
Solutions are innovative and consistent with organization objectives
Completes work; independently receives general guidance on new projects
Work reviewed for purpose of meeting objectives
May act as a mentor to less experienced colleagues

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.