Sr. Specialist, Quality Assurance
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. 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 (science) 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 highly preferred
- Pharmaceutical or medical device experience a plus.
- Effective written and verbal English communication skills.
- ISO experience a plus.
- Ability to lift up to 30-45 lbs.
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
- 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
