05 Nov
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Jubilant DraxImage
|
Kirkland
05 Nov
Jubilant DraxImage
Kirkland
Lead quality technology transfer across PET manufacturing sites from a home-based role, applying cGMP expertise and traveling approximately 40-60%.
Jubilant Radiopharmacies seeks a Quality and Compliance Specialist for a two-year contract. You will guide technology transfer projects across Operations, Validation, and project teams, supporting product launches, site startups, customer transfers, and commercial implementation. The work requires pharmaceutical Quality experience, sterile manufacturing knowledge, and familiarity with validation documentation.
Key Responsibilities:
- Represent Quality across PET technology transfer projects
- Review plans, change controls, risk assessments, and GMP records
- Assess quality gaps between transferring and receiving sites
- Facilitate ICH Q9 risk assessments and mitigation plans
- Support readiness, investigations, CAPAs, audits, and inspections
Requirements:
- Bachelor's degree in Science, Engineering, or related field
- Minimum five years of pharmaceutical Quality experience
- Minimum three years supporting sterile manufacturing operations
- Experience with technology transfer, validation, and commercial manufacturing
- Knowledge of FDA requirements, ICH Q9, USP <825>, and cGMP
Apply quality leadership, technology transfer, and sterile manufacturing expertise across Jubilant Radiopharmacies' PET network.
📌 Quality Technology Transfer Specialist (Kirkland)
🏢 Jubilant DraxImage
📍 Kirkland