Documentation Control Specialist

Overview

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 that selectively destroy cancer cells while limiting impact on surrounding healthy cells.

The Document Control Specialist will manage the organization, tracking, and compliance of all Orano Med ATLab-IN documents. The role includes coordinating document creation, revision, distribution, and archiving, and maintaining accurate records in our electronic Quality Management System (QMS) and DOT Compliance.

• Manage the document control process, including creation, review, approval, distribution, and archiving of documents.
• Ensure all documents comply with company policies and regulatory requirements.
• Maintain and update the document management system for easy retrieval.
• Collaborate with various departments to gather and prepare documentation for projects, audits, and inspections.
• Conduct regular audits of document control processes to identify areas for improvement.
• Provide training and support to staff on document control procedures and tools.
• Assist in the development and maintenance of document control procedures and best practices.
• Generate reports on document status and compliance for management review.
• Facilitate the flow of information between teams and stakeholders regarding document updates and revisions.
• Create and distribute Batch Record packages via the electronic QMS according to Orano Med ATLab-IN manufacturing schedules.
• Oversee the documentation library, including issuing, receiving, and tracking validation packages, batch records, logbooks, etc.
• Adhere to Good Manufacturing Practices (GMP), procedures, and Orano Med ATLab-IN policies and procedures.
• Participate in problem‑solving tasks and collaborate with various Orano Med ATLab-IN disciplines to ensure timely document creation and delivery.
• Oversee the biennial review process for controlled documents and manage records related to local and off‑site document storage.
• Act as a subject‑matter expert or cross‑train other staff in the documentation control area.
• Perform other related duties as assigned or required.

• Associate’s degree or equivalent (60 college credit hours) with two years of relevant experience, or
• High School Diploma with four or more years of experience in a quality or production‑related role within a GMP environment.

• Proven experience in document control or records management, preferably in the pharmaceutical industry.
• Strong attention to detail and organizational skills.
• Proficiency in document management systems and Microsoft Office Suite.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.

• Competitive compensation.
• Health, Dental, and Vision insurance with generous employer contributions.
• 401(k) with employer matching and contribution amounts.
• Life and Short‑ and Long‑Term Disability insurance.
• Generous paid time off and holiday schedules.
• Numerous training and development opportunities.

In compliance with federal law, all persons hired must verify identity and eligibility to work in the United States and complete the required employment eligibility verification upon hire. This position requires a pre‑employment background check and drug screening.

Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. All personnel actions—recruitment, compensation, career development, benefits, and company‑sponsored training—are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran status, or other protected status.