GMP QA Specialist - Sterile & Documentation

Orano Med, LLC.; Plano (TX); On-site; USD 52,000 - 78,000; Full time

Benefits offered by this job

Health, Dental & Vision insurance

401(k) with employer matching

Life insurance

Disability insurance

PTO & holidays

Training & development

Job summary

Orano Med, LLC. in Plano, TX is seeking a Quality Assurance Technician to support GMP manufacturing of raw materials and sterile drugs for clinical trials. You will review documentation, release materials, and assist with quality systems improvements to ensure compliance.

The role requires a science degree, SOP writing experience, strong communication, and the ability to manage multiple projects. You will work in an in-office environment with collaboration across QA, manufacturing, and R&D teams.

Qualifications

• BS in science or related field required.
• Experience writing GMP docs and SOPs.
• Strong communication and organizational skills.

Responsibilities

• Inspect, review documentation, and release incoming raw materials and packaging components.
• Update 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
• Other duties as assigned.

Skills

SOP writing

GMP documentation

MS Office

Communication

Organization

Multitasking

Education

Bachelor's degree in science related field

Job description

Orano Med, LLC. in Plano, TX is seeking a Quality Assurance Technician to support GMP manufacturing of raw materials and sterile drugs for clinical trials. You will review documentation, release materials, and assist with quality systems improvements to ensure compliance.

The role requires a science degree, SOP writing experience, strong communication, and the ability to manage multiple projects. You will work in an in-office environment with collaboration across QA, manufacturing, and R&D teams.