GMP QA Technician in Life Sciences

Orano Projects Limited

Plano, Northern (TX, KY)

Hybrid

USD 70,000 - 100,000

Full time

11 days ago
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Benefits offered by this job

Competitive compensation
Health, Dental, Vision insurance
401(k) with employer matching
Life insurance
Paid time off
Training and development opportunities

Job summary

Orano Med is seeking a QA Specialist to support GMP manufacturing of raw materials and sterile drugs for clinical trials. The role involves reviewing documentation, releasing materials, and dispositions while contributing to quality systems improvements across procedures.

This position requires strong writing, attention to detail, and the ability to juggle multiple projects in a fast-paced biotech environment.

Qualifications

  • Experience writing GMP documentation and SOPs.
  • Proficient in Microsoft Office (Excel, Word, PowerPoint).
  • Strong written and verbal communication skills.
  • Excellent organizational abilities and project juggling.
  • Ability to manage multiple projects with changing priorities.

Responsibilities

  • Inspect, review documentation, and release incoming raw materials and packaging components.
  • Review production batch records, logbooks, and related documentation for SOP compliance.
  • Release/disposition GMP products for Macrocyclics and OM.
  • Oversee sterile manufacturing processes and provide gowning instruction.
  • Support internal audits, CAPA, and change controls as directed.

Skills

SOP writing
GMP documentation
MS Office
Communication
Organization
Multi-project work

Education

Bachelor's degree in science

Tools

Microsoft Excel
Microsoft Word
PowerPoint

Job description

Orano Med is seeking a QA Specialist to support GMP manufacturing of raw materials and sterile drugs for clinical trials. The role involves reviewing documentation, releasing materials, and dispositions while contributing to quality systems improvements across procedures.

This position requires strong writing, attention to detail, and the ability to juggle multiple projects in a fast-paced biotech environment.

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