Sr. Specialist, Quality Assurance

Cardinal Health

About The Position

The Senior Specialist, Quality Assurance ensures the safe handling of pharmaceutical and medical products by overseeing temperature excursion events and evaluating product stability to protect patient safety. This position serves as the primary contact with manufacturers, supports facilities with excursion documentation, and maintains key stability and excursion data. The role also contributes to the Quality Management System by administering temperature monitoring platforms, assisting with temperature studies across multiple facilities, and supporting related projects. Success requires strong attention to detail, effective prioritization, independent work, and sound judgment within established guidelines.

Requirements

Bachelor’s degree in a related field or equivalent experience preferred.
Minimum of 2 years of relevant experience preferred.
Strong attention to detail.
Ability to manage timelines and prioritize tasks effectively.
Ability to work independently with minimal direction.
Proven ability to multitask.
Applies working knowledge of concepts, principles, and technical capabilities to perform a variety of tasks.
Contributes to projects of moderate complexity and scope.
Identifies and implements solutions to a range of technical issues.
Exercises sound judgment within established guidelines.
Works under general guidance, receiving more detailed instruction for new assignments.
Work is reviewed for sound reasoning and accuracy.

Nice To Haves

Certified Pharmacy Technician or other Health Care Professional certification strongly preferred.

Responsibilities

Temperature Disposition Processing Contact manufacturers regarding temperature excursions and evaluate the resulting stability data to ensure products remain safe and compliant.
Escalate issues that may lead to a Cardinal Health–initiated product recall.
Maintain a comprehensive database of temperature excursions and manufacturer stability data.
Provide support to site personnel when temperature excursions occur.
Use Microsoft tools—including SharePoint—on a daily basis.
Support for Quality Systems (Pharmaceutical & Medical Distribution) Serve as a system administrator for temperature monitoring platforms, including Digi SmartSense.
Participate in assigned temperature management projects.
Assist with temperature studies for more than 75 facilities.
Serve as a backup for the Canada temperature management.