Principal Specialist, Quality Assurance

Cardinal Health•GA-Georgia-Work from Home, GA

8d•$80,900 - $103,950

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.

Requirements

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

Nice To Haves

4-8 years of experience, preferred
Bachelor's degree in related field, or equivalent work experience, preferred

Responsibilities

Contributing to design effective quality systems, procedures, work instructions and/or processes to ensure compliance as well as efficiency throughout the quality system.
Processing eQMS records to closeout.
Customer Complaints
Issue Records
Nonconformance Records
CAPA/SCAR Records
Change Controls
Evaluating QMS records for potential trends.
Supporting Monthly Metrics
Performing internal assessments to: Determine compliance to processes and regulations, Identify potential gaps and mitigate, Implement improvements within our quality system.
Contributing to the training program for various aspects of CAHPPL including preparation of the annual cGMP and Pharmacovigilance training presentation/course.
Works on complex projects.
Acts as a mentor to those with less experience.
Other activities as requested.