QA Specialist: GMP & Sterile Manufacturing

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

Benefits offered by this job

Health, Dental, Vision insurance

401(k) with employer matching

Life insurance

Short- and Long-Term Disability

Paid Time Off and holidays

Training and development opportunities

And more…

Job summary

Orano Med seeks a QA Specialist to support GMP manufacturing of raw materials and sterile drugs for clinical trials. You will review materials documentation, disposition batches, and assist with quality systems improvements.

Responsibilities include releasing incoming materials, updating SOPs, overseeing sterile processes, and auditing GMP labs. A science-related degree and GMP documentation experience are required.

Qualifications

• Bachelor’s degree in science-related field required.
• Experience in writing SOPs and GMP documentation.
• Proficient in MS Office (Excel/PowerPoint) with strong written and verbal communication.

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 and provide gowning guidance.
• Review production batch records and related documentation for SOP compliance.
• Review equipment/instrumentation documentation to support GMP operations.
• Scan manufacturing documentation including batch records, audits, CAPAs, and change controls.
• Release/disposition GMP products for Macrocyclics and OM.
• Follow up on investigations, CAPAs, and change controls for timely closure.
• Review documentation related to technology transfer from R&D for manufacturing.
• Perform internal audits of GMP labs and other non-GMP processes.

Skills

SOP writing

MS Office

Excel

PowerPoint

Written communication

Organization

Multitasking

Education

Bachelor’s degree in science-related field

High Diploma/GED

Job description

Orano Med seeks a QA Specialist to support GMP manufacturing of raw materials and sterile drugs for clinical trials. You will review materials documentation, disposition batches, and assist with quality systems improvements.

Responsibilities include releasing incoming materials, updating SOPs, overseeing sterile processes, and auditing GMP labs. A science-related degree and GMP documentation experience are required.