GMP QA Specialist – Sterile Manufacturing & Compliance

Orano; Plano (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

GMP knowledge

Documentation review

Quality assurance

Disposition of materials

Tools

SOPs

CAPA

Change control

Job description

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.