QA Specialist III

Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.

With a solid portfolio of development projects covering a diverse range of biological molecules capable of recognizing and targeting various forms of cancerous tumors, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular addressing needs of patients currently without effective therapeutic solutions among the existing approaches.

Position Summary

The Quality Assurance (QA) Specialist is responsible for ensuring the products and processes meet established quality standards and regulatory requirement. This role supports production and quality control (QC) testing operations by performing audits, reviewing documentation, investigating deviations, and promoting continuous improvement across the site.

Key Responsibilities

• Monitor and enforce compliance with internal procedures, industry standards, and regulatory requirements (e.g., FDA, ISO, Good Manufacturing Practices (GMP)).
• Conduct in-process inspections, environmental monitoring reviews, and final product reviews.
• Author, review and approve batch records, procedures, and other quality-related documentation.
• Act as lead investigator for non-conformances, deviations, customer complaints, and assist in root cause analysis, and corrective/preventive actions (CAPA).
• Collaborate with cross-functional teams (e.g., Production, QC, Facilities, etc.) to support quality initiatives and resolve issues.
• Lead site internal audits and partner audits along with support external inspections.
• Serve to corrdinate training for new personnel and provide guidance to site QA procrdures and best practices.
• Maintain records and documentation in accordance with company policies and regulatory standards.
• Support qualification and validation activities (e.g., equipment, systems, processes)
• Escalate quality concerns appropriately and timely to ensure product integrity and patient safety.
• Act as backup in assigning tasks and managing quality initiatives in absence of department leaders.
• Perform other related duties as assigned or required.

Qualifications

Education

• Bachelor's degree in scientific or technical discipline (e.g., Biology, Chemistry, Engineering) preferred.
• Four plus years of experience in a regulated industry (e.g., pharmaceutical, biotech, medical devices, food manufacturing)

Experience

• Strong understanding of GMP, GLP, and other relevant quality standards.
• Strong attention to detail and organizational skills.
• Proficiency in quality management systems and Microsoft Office Suite.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Flexibility to work assigned shift and occasional weekends or holidays as needed.

Work Skills

• Demonstrate ability to mobilize cross-functional teams through influence and inspiration
• Strong problem-solving skills and the ability to prioritize task effectively.
• Proficient with word processing, spreadsheet, and database software, and standard business communication tools (e.g., Microsoft Outlook).
• Ability to prioritize and manage a high volume of complex activities with rapidly changing priorities.
• Excellent written and verbal communication skills in English.
• Detail-oriented with the ability to meticulously compare details in multi-page documents while managing urgent customer needs.
• Demonstrated team participation with leadership behaviors is preferred.

Attitude