Senior Specialist, Quality Assurance
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 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, or equivalent work experience, preferred
- 2-4 years of experience, 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.
- Ability to manage several tasks at the same time and evaluate operating conditions
- 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
- Ensure 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
- Engage and collaborate with operations department to drive quality system and CGMP requirements
- Performs product release activities per CGMP requirements
- Report quality system issues to the Regional Quality Manager. This includes timely escalation of discrepancies upon identification
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
