Documentation Control Specialist

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.

The Document Control Specialist will be responsible for the management, organization, and tracking of all Orano Med ATLab-IN documents to ensure compliance with industry standards and internal policies. This role will involve coordinating document creation, revision, distribution, and archiving as well as maintaining accurate records in our electronic Quality Management System (QMS), DOT Compliance.

Key Responsibilities

• Manage the document control process, including the creation, review, approval, distribution, and archiving of documents.
• Ensure that all documents comply with company policies and regulatory requirements.
• Maintain and update the document management system to ensure easy retrieval and reference.
• 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/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.
• May act as a Subject Matter Expert or cross-train other staff in the documentation control area.
• Perform other related duties as assigned or required.

Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification from 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. We ensure that all personnel actions such as 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, or other protected status. 

Qualifications

Education

• Associate’s degree or equivalent (60 college credit hours) with two (2) years of relevant experience, or
• High School Diploma with four (4) or more years of experience in a quality or production-related role within a GMP environment.

Experience

• 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.

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 higher-level position.