Documentation Control Specialist

Job Information

Title:

Documentation Control Specialist

Location:

Brownsburg, Indiana, United States

Orano Med, a subsidiary of Orano USA, is focused on nuclear medicine research and the development of lead‑212 based therapies for cancer treatment. The Documentation Control Specialist will manage, organize, and track all documents within the ATLab‑IN to ensure compliance with industry standards and internal policies.

• Manage the document control process, including 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 for 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 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 ATLab‑IN policies/procedures.
• Participate in problem‑solving tasks and collaborate with various 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.

Education

• Associate’s degree or equivalent (60 college credit hours) with at least 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.

The position requires a pre‑employment background check and drug screening. All candidates must verify identity and eligibility to work in the United States upon hire.

• Competitive compensation
• Health, dental, and vision insurance with generous employer contributions
• 401(k) with employer matching and contribution amounts
• Life insurance and short‑ and long‑term disability insurance provided by the company
• Generous paid time off and holiday schedules
• Numerous training and development opportunities
• And more

Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. 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.