Senior QA Specialist: Tech Transfer & cGMP Compliance

Hobbsnews; Fort Lauderdale (FL); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

401k plan

MyFlexPay access

FSAs

Disability coverage

Work-Life resources

Parental leave

Wellness programs

Job summary

Cardinal Health PET Manufacturing Services is seeking a Senior Specialist, Quality Assurance to support Nuclear Manufacturing. The role anchors on tech transfer projects within a growing Technical Operations team, with site QA leadership and cross-functional collaboration.

The position involves extensive QA review, cGMP compliance, and travel across the PET sites. On-site at a PET manufacturing facility in Florida, with flexible shifts and potential weekend coverage.

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.

Responsibilities

• Provide QA support for review and approval of operational documentation related to tech transfer projects.
• Travel to other PET manufacturing sites to review technical transfer projects.
• Perform cGMP documentation review for release, facilities, equipment, controls, and packaging.
• Establish and report metrics related to products and processes.
• Ensure site compliance with 21 CFR 212 (cGMP).
• Handle and archive documentation supporting cGMP activities.

Skills

English communication

Quality systems

Analytical skills

Education

Bachelor's degree or equivalent

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. The role anchors on tech transfer projects within a growing Technical Operations team, with site QA leadership and cross-functional collaboration.

The position involves extensive QA review, cGMP compliance, and travel across the PET sites. On-site at a PET manufacturing facility in Florida, with flexible shifts and potential weekend coverage.