Senior QA Specialist – PET Manufacturing & Tech Transfer

Cardinal Health; Tallahassee (FL); On-site; USD 68,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Paid parental leave

Job summary

Cardinal Health PET Manufacturing Services is seeking a Senior Specialist, Quality Assurance to support Nuclear Manufacturing and tech transfer projects across the network of PET facilities. The role emphasizes QA review of technical transfer documentation and cGMP compliance.

The position requires travel 50%-75% and onsite work in a PET manufacturing facility in Fort Lauderdale, FL, with responsibilities spanning documentation, CAPA, and product release in a regulated environment.

Qualifications

• Bachelor's degree in related field, or equivalent work experience, preferred
• 2+ years of experience in related science field preferred
• 1-2 years of experience in Quality Assurance and/or regulated environment preferred; cGMP, 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; Ability to focus on tasks; Ability to evaluate operating conditions.
• Ability to travel 50%-75%.

Responsibilities

• Deliver QA support for the review and approval on all operational documentation related to tech transfer projects
• Travel to other PET manufacturing sites to provide quality review of tech transfer projects
• Handle 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 to products and processes
• Ensure site manufactures products to meet 21 CFR 212 (cGMP)
• Perform product release activities per cGMP requirements
• Monitor CAPA in investigations and close when completed or escalate as needed
• Review and disposition manufacturing batch records and related docs

Skills

English communication

Travel 50-75%

Quality system understanding

Problem solving

Analytical skills

Education

Bachelor's degree in related field

Tools

SAP

Microsoft Excel

Microsoft Word

Microsoft Outlook

PowerPoint

Job description

Cardinal Health PET Manufacturing Services is seeking a Senior Specialist, Quality Assurance to support Nuclear Manufacturing and tech transfer projects across the network of PET facilities. The role emphasizes QA review of technical transfer documentation and cGMP compliance.

The position requires travel 50%-75% and onsite work in a PET manufacturing facility in Fort Lauderdale, FL, with responsibilities spanning documentation, CAPA, and product release in a regulated environment.