Document Control Specialist

Orano Med is seeking a detail-oriented Document Control Specialist radiopharmaceutical manufacturing at ATLab Indianapolis ("ATLab IND"), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals.

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.

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.

Our Full-Time Benefits

• 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...

Qualifications Required

Education

• Associate's degree or equivalent (60 college credit hours) with 2 years of relevant experience, or
• High School Diploma (or equivalent) with 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.

Work Skills

• Strong problem-solving skills and the ability to prioritize tasks 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

• Demonstrated team participation with leadership behaviors is preferred.

Please Note: The provided salary information is a guideline. Your offered salary is based upon experience, qualifications, geographic location, as well as market and business considerations.

Salary range annually: $65,000 - $90,000

Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.