Senior QA Specialist — Tech Transfer & cGMP

Cardinal Health

Fort Lauderdale (FL)

On-site

USD 90,000 - 120,000

Full time

4 days ago

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Job summary

Cardinal Health PET Manufacturing Services is seeking a Senior Specialist in Quality Assurance to support Nuclear Manufacturing and drive technology transfer projects within a growing Technical Operations team.

The role focuses on QA review of technical transfer documents, cGMP compliance, and cross-site collaboration to ensure product quality from development through implementation across our PET manufacturing network.

Qualifications

Bachelor's degree in related field or equivalent experience.
2+ years in a related science field preferred; cGMP experience preferred.

Responsibilities

Provide QA support for review/approval of tech transfer documents (protocols, validation docs).
Travel to PET sites network-wide to review tech transfer projects.
Handle cGMP documentation related to product release, facilities, equipment, materials, lab controls, packaging, and process controls.
Establish and report product/process metrics as directed by the Regional Quality Manager.
Ensure site manufacturing meets 21 CFR 212 (cGMP) requirements.
Manage and archive cGMP documentation; support quality system improvements.
Escalate discrepancies promptly and coordinate with Operations to drive quality culture.
Review and disposition manufacturing batch records, validation docs, change controls, and related records.