Senior Specialist, Quality Assurance

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.

Job Summary The Senior Specialist, Quality Assurance role will support, Nuclear Manufacturing. This is part of a growing Technical Operations team within Cardinal Health’s Nuclear and Precision Health Solutions organization tasked with the development and technology transfer of radiopharmaceutical products into and among our network of qualified manufacturing facilities. Tech Transfer projects are the leading priority for this Quality Assurance position.

• Deliver QA support for the review and approval on all operational documentation as it relates to the technical transfer project such as protocols, validation documents, etc. This role will be accountable to the technical transfer leadership team while executing tech transfer projects.
• Travel to other PET manufacturing sites network-wide to provide quality review of technical transfer projects when required.
• Handle cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls. Establish metrics and report as required by the Regional Quality Manager.
• Ensure the site manufactures products to meet the requirements of 21 CFR 212 (cGMP). Handle and ensure quality of documentation (control, retention, and archival) to support cGMP activities. Engage and collaborate with Operations department to drive quality system and cGMP requirements.
• Perform product release activities per cGMP requirements. Monitor CAPA in investigations and close when completed or escalates if necessary.
• Perform aseptic review of the site with Operations and document results. Report quality system issues to the Regional Quality Manager and others as necessary.
• Review and disposition documentation in a timely manner, such as manufacturing batch records, EM records, validation documentation, change controls, process qualifications, on-site material preparations, equipment qualifications and/or planned maintenance, material acceptance, cleaning documents, etc.
• Work cross-functionally and interpret requirements, educate and influence others on those requirements.

• Bachelor's degree in related field, or equivalent work experience.
• 2+ years of experience in related science field (preferred).
• 1-2 years of experience in Quality Assurance and/or regulated environment (preferred).
• cGMP experience, highly preferred.
• Pharmaceutical or medical device experience, a plus.
• ISO experience, a plus.
• Effective written and verbal English communication skills.
• Ability to manage several tasks at the same time; focus on tasks; evaluate operating conditions; exercise sound judgment.
• Personal Protective Equipment experience.
• Knowledge of quality systems and approaches.
• Proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft Power Point.
• Understanding of requirements and gap assessments.
• Ability to analyze…