Orano USA · 1 day ago
Quality Assurance Specialist
Plano, TX
Full-time
Onsite
New Grad, Entry LevelOrano USA is a dynamic, mission-driven organization transforming oncology from the inside out. They are seeking a Quality Assurance Specialist to support GMP manufacturing of raw materials and sterile drugs for clinical trials, ensuring the highest standards in pharmaceutical manufacturing.
Utilities
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 practice instruction
Review production batch records, logbooks, and associated documentation to assess completeness, accuracy, and compliance with SOPs
Review of equipment and instrumentation documentation in support of GMP manufacturing and testing 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
Qualification
Required
Experience in Quality Assurance within a pharmaceutical manufacturing environment
Knowledge of GMP regulations and compliance
Ability to review and assess documentation for completeness and accuracy
Experience with batch records and quality systems
Familiarity with sterile manufacturing processes
Strong attention to detail and ability to work in a fast-paced environment
Ability to perform internal audits of GMP and non-GMP processes
Strong communication skills for providing instructions and following up on investigations
Company
Orano USA
U.S. advanced reactor services, uranium enrichment, uranium sales, used nuclear fuel management, federal services, and nuclear medicine.
Founded in 2017
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase