Senior Specialist, Quality Compliance

Cardinal Health•La Vergne, TN

9d•$57,000 - $73,440•Onsite

About The Position

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Compliance is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity.

Requirements

Bachelor's degree in related field, or equivalent work experience, preferred
2-4 years of experience, preferred
Experience with Good Manufacturing Practices (GMP) or distribution within the medical or pharmaceutical industry, preferred
Experience with MS Office Suite
Strong organizational skills and attention to detail
Strong technical aptitude with the ability to effectively work within systems and utilize various software tools

Responsibilities

Supporting activities associated with regulatory, vendor, and facility audits including, but not limited to, maintaining inspection readiness, executing audit support in gathering documentation and coordinating cross-functionally with other departments, conducting monthly warehouse audits to ensure compliance with all applicable SOPs and coordinating resolution with Quality Compliance Officer and Operations for storage and facility observations.
Managing learning management systems and reporting which includes training assignments, exam creations, and reporting.
Creating and executing quality management system (QMS) events such as nonconformances, complaints, and CAPAs.
Completing product dispositions to include but not limited to assembling product information and coordinating cross-functionally with Operations and corporate Quality teams.
Assisting in the pulling of daily temperature data and monthly humidity data, assisting with the execution and data gathering to support temperature mapping activities, and assisting in the execution of site and material qualifications.