Senior Specialist, Quality Assurance

Cardinal Health•Dallas, TX

4d•Onsite

About The Position

What Quality Assurance contributes to Cardinal Health 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. Cardinal Health Positron Emission Tomography (PET) Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

Requirements

Bachelor’s degree in related field preferred, or equivalent work experience preferred.
2+ years of experience in related science field preferred
1-2 years of experience in Quality Assurance and/or cGMP regulated environment preferred
Effective written and verbal English communication skills.
Ability to lift up to 30-45 lbs.
Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
Works on projects of moderate scope and complexity
Identifies possible solutions to a variety of technical problems and takes action to resolve
Applies judgment within defined parameters
Receives general guidance and may receive more detailed instruction on new projects
Work reviewed for sound reasoning and accuracy

Nice To Haves

Pharmaceutical or medical device experience a plus.
ISO experience a plus.

Responsibilities

Handles cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager (RQM).
Ensures the site manufactures products to meet the requirements of 21 CFR 212 (cGMP).
Handles and ensures quality of documentation (control, retention, and archival) to support cGMP activities.
Engages and collaborates with operations department to drive quality system and cGMP requirements.
Performs product release activities per cGMP requirements.
Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification.

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs