Senior QA Specialist, Tech Transfer – Radiopharma

Cardinal Health; Fort Lauderdale (FL); Hybrid; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account

401k savings plan

Wages advance via myFlexPay

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Senior Specialist, Quality Assurance to support Nuclear Manufacturing and tech transfer projects. You will review and approve operational docs, coordinate with site leadership, and ensure cGMP compliance across the network of PET manufacturing facilities.

The role requires travel 50–75%, experience with QC, QC documentation, and strong written/verbal English skills. Competitive salary with comprehensive benefits in a manufacturing environment.

Qualifications

• 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 and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner, a plus.
• Understanding of quality concepts such as cost of quality, analytical metrics and/or statistics, trending, quality planning, validation, CAPA and problem solving, a plus.
• Ability to travel 50%-75%.

Responsibilities

• 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.

Skills

English communication

Quality systems knowledge

Chromatogram analysis

Travel availability

Education

Bachelor's degree in related field

Tools

SAP

Microsoft Excel

Microsoft Word

Microsoft Outlook

Microsoft PowerPoint

Job description

Cardinal Health is seeking a Senior Specialist, Quality Assurance to support Nuclear Manufacturing and tech transfer projects. You will review and approve operational docs, coordinate with site leadership, and ensure cGMP compliance across the network of PET manufacturing facilities.

The role requires travel 50–75%, experience with QC, QC documentation, and strong written/verbal English skills. Competitive salary with comprehensive benefits in a manufacturing environment.