Document Control Specialist

Job Opportunity

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging whats possible and making headway to help improve outcomes.

Responsibilities

• Responsible for supporting the maintenance of the document control system during 1st shift.
• Day-to-day management of resources, planning to meet goals and deadlines.
• This role ensures compliance within the document management system, document storage, retention, and document reconciliation.
• Serve as a document control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures as needed.
• Ability to manage multiple and complex projects, provide status reports, and coordinate with cross-functional departments.
• Support Document management system users with workflow handling and electronic system usage as needed.
• Manage the periodic review process for procedures as needed.
• May identify and implement process-level efficiencies.
• Drive continuous improvement.
• Maintains all ISO / FDA standard operating procedures, work instructions, and forms.
• Maintains revision and approval status of all documents.
• Maintains hard copies of all approved documentation.
• Maintains appropriate templates for access.
• Tracking, follow-up, and implementation of, including but not limited to, ECRs, DCRs, ECOs, DCOs, and MCOs. Deviations, validation records, batch records, and notebooks.
• Responsible for processing change orders through the Agile PLM system.
• Support internal audits when needed.
• Supports external audits when needed.
• Issues controlled documentation such as batch records and validations.
• Have advanced computer skills to increase department productivity, as well as broadening technical and scientific knowledge.

Qualifications