Quality Assurance Technician

Orano; Plano (TX); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

Orano Med is hiring a QA Specialist to support GMP manufacturing of raw materials and sterile drugs for clinical trials. You will review documentation, release materials, and help drive quality system improvements.

Responsibilities include overseeing sterile processes, updating SOPs, and ensuring compliance with SOPs, CAPA, and change control activities across QA and manufacturing teams.

Qualifications

• Experience reviewing GMP documentation and releasing materials.
• Understanding of quality systems and regulatory expectations.
• Ability to perform internal audits and support investigations.

Responsabilités

• Inspect, review documentation, and release incoming raw materials and packaging components.
• Update Quality SOPs and perform secondary review of documentation.
• Perform area release for manufacturing, as needed.
• Oversee sterile manufacturing process, provide gowning and practices instruction.
• Review production batch records, logbooks, and related documentation for SOP compliance.
• Review equipment/instrumentation documentation for GMP operations.
• Scan manufacturing documentation including batch records, audits, CAPA, and change control.
• Release/disposition GMP products for Macrocyclics and OM.
• Follow up on investigations, CAPAs, and change controls for timely completion.
• Review documentation related to technology transfer from R&D to manufacturing.

Connaissances

GMP knowledge

Documentation review

Quality assurance

Disposition of materials

Outils

SOPs

CAPA

Change control

Description du poste

Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

The QA Specialist supports GMP manufacturing of raw materials and sterile drugs for clinical trials. The individual in this role will review documentation related to raw materials, components, and completed batch records followed by giving a disposition of each. Assist with quality systems improvements.

Key Responsibilities:

• Inspect, review documentation, and release incoming raw materials and packaging components.
• Update Quality SOP’S and perform secondary review of documentation.
• Perform area release for manufacturing, as needed.
• Oversee sterile manufacturing process, provide sterile gowning and practices instruction.
• Review production batch records, logbooks, and associated documentation to assess completeness, accuracy, and compliance with SOPs.
• Review of equipment / instrumentation documentation in support of GMP operations.
• Scanning manufacturing documentation such as batch records, raw materials, audits, investigations, CAPA, and change control.
• Release/disposition GMP products for Macrocyclics and OM.
• Follow up on investigations, CAPAs and change controls for time completion.
• Review of documentation related to technology transfer from R&D for manufacturing activities.
• Perform Internal audits of GMP labs and other non-GMP processes as directed