QA Scientist

Orano Med Theranostics

Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

Orano Med LLC has opening for Quality Scientist in Plano, TX.

This position ensures drug products, manufacturing processes, and quality systems comply with regulatory, safety, and performance standards from early development through clinical phase 2 by collaborating with manufacturing, R&D, and quality teams while integrating sound scientific principles with Good Manufacturing Practices (GMP) expertise to drive continuous improvement, mitigate risks, and maintain compliance with FDA, EMA, and global regulations. The Quality Scientist investigates deviations, implements CAPAs from Analytical data review while supporting technology transfers, optimization and validation efforts. Success demands strong analytical skills, attention to detail, and the ability to translate complex issues into practical, compliant solutions that prioritize product integrity and patient safety.

Key Responsibilities

• Conduct thorough technical review and approval of raw data, chromatograms, calculations, instrument audit trails, and analytical reports generated by QC analysts to verify accuracy, completeness, and compliance.
• Lead continuous improvement activities for the verification / qualification / validation program to ensure efficiency, effectiveness, and regulatory compliance through trend analysis of analytical data.
• Conduct effective in-depth investigations, driving efforts to reduce non-conforming issues and implement preventive measures.
• Technical review and approval of transfer and validation documentation and technical review of all data generated in accordance with FDA regulations/guidelines.
• Review, analyze, and assess manufacturing processes, R&D recommendations, quality procedures and regulatory guidance to initiate product quality improvements.
• Generation, review, approval and maintenance of cleaning validation activities.
• Perform complex tasks to ensure delivery of high quality of products and processes from design through manufacturing.
• Other duties as assigned.

Requirements

All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.

Minimum Qualifications

• Bachelor's of Science (or higher) in Chemistry or other related field
• 7+ years experience in Pharmaceuticals
• 5+ years experience as a Quality Engineer

Preferred Skills & Competencies

• Strong experience performing technical review of Analytical Data
• Experience writing SOPs and other associated GMP documentation
• In-depth knowledge of cGMP, GLP, FDA/EMA regulations, ICH guidelines, USP/EP pharmacopeial methods, and data integrity principles.
• Proficient in Microsoft Office, Excel, and Power Point
• Excellent technical writing and verbal communication skills.
• Strong organization skills and attention to detail.
• Able to easily switch between multiple ongoing projects, adjusting priorities based on business needs.