QA Specialist III

Orano

CDIPrésentielConfirmé (3–5 ans)

À propos du poste

Orano Med, a subsidiary of Orano USA, is at the forefront of nuclear medicine research, developing innovative targeted alpha therapies against cancer. The QA Specialist III plays a critical role in ensuring that products and processes meet stringent quality standards and regulatory requirements in this highly regulated environment. This position supports production and quality control operations across the Brownsburg site, serving as a guardian of product integrity and patient safety. The ideal candidate will be experienced in GMP-regulated industries, capable of conducting audits, investigating deviations, and driving continuous improvement initiatives. You will collaborate with cross-functional teams, lead root cause analyses, and ensure full compliance with FDA, ISO, and GMP standards. This role offers the opportunity to contribute to breakthrough cancer therapies while maintaining the highest quality and regulatory standards in nuclear medicine production.

Vos missions

Monitor and enforce compliance with FDA, ISO, GMP standards and internal procedures
Conduct in-process inspections, environmental monitoring reviews, and final product reviews
Author, review and approve batch records, procedures, and quality-related documentation
Lead investigation of non-conformances, deviations, and customer complaints with root cause analysis
Lead site internal audits and partner audits, support external regulatory inspections
Collaborate with cross-functional teams to support quality initiatives and resolve issues
Coordinate training for new personnel on QA procedures and best practices
Support qualification and validation activities for equipment, systems, and processes

Profil recherché

Bachelor's degree in scientific or technical discipline (Biology, Chemistry, Engineering)
Four+ years of experience in regulated industries (pharmaceutical, biotech, medical devices)
Strong understanding of GMP, GLP, and relevant quality standards
Proficiency in quality management systems and Microsoft Office Suite
Excellent written and verbal communication skills
Strong attention to detail and organizational skills
Ability to work independently and collaboratively in team environment
Flexibility to work assigned shifts and occasional weekends/holidays

Un plus si vous avez

Experience in nuclear medicine or radiopharmaceutical manufacturing
Knowledge of targeted alpha therapy or radioisotope handling
Experience with FDA inspection preparation and audit management
Familiarity with quality management software systems
Project management or Lean/Six Sigma certification

Compétences clés

GMPFDA ComplianceQuality AssuranceAudit ManagementCAPADocumentationRegulatory AffairsRoot Cause AnalysisCross-functional LeadershipNuclear Medicine

À propos de Orano

Orano

Nucléaire

10 000+ employésChâtillon, France

Orano, anciennement Areva NP, est un groupe industriel spécialisé dans le cycle du combustible nucléaire : extraction d'uranium, conversion, enrichissement, fabrication de combustible, traitement et recyclage des matières nucléaires. Présent dans 17 pays avec environ 17 000 collaborateurs, Orano est un acteur stratégique de la filière nucléaire civile mondiale et un partenaire incontournable des exploitants de centrales.

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