Document Control Specialist

INCOG BioPharma Services • Fishers, IN

4d • Onsite

About The Position

Working closely with the Document Control Supervisor, the Specialist will be instrumental in developing and championing our new organization’s approach to the design, approachability, control, and training of content.  The Specialist will manage the flow of documents, records, and subject matter experts, and own the logistical operations for all site inspections. The Specialist will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments.  The Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.  The Specialist will have strong familiarity with Microsoft word processing and spreadsheet management software.  They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills.  The Specialist will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes.

Requirements

• Bachelor’s degree required.
• Minimum of 2 years’ experience in a regulated industry.
• Minimum of 3 years’ experience designing, writing, and/or editing documents of a technical nature.
• Minimum of 3 years’ experience with internal customer service, support/troubleshooting and/or training/presenting publicly.
• Exceptional computer skills, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.
• Able to lift and move boxes of up to 50 lbs and stand for moderate periods of time.

Nice To Haves

• Bachelor’s degree in a science field or Language/Communications.
• Certification in Technical Writing or Information Management.
• Microsoft Office Specialist or Expert certification in Word and/or Excel.
• Moderate to expert level experience with Microsoft PowerPoint, Visio and/or other presentation software packages.
• Experience as a user of an electronic GxP management system (eDMS, eLMS, eQMS, LIMS, CMMS, etc.); Administrator experience highly preferred.
• Experience/comfort with industrial copiers/printers and scanners.

Responsibilities

• Administer the routing, review, release, and retirement of controlled documents in an electronic document management system.
• Administer the requirements for documents and other materials for training in an electronic learning management system.
• Manage the issuance, control, and reconciliation of a controlled copy and record program including Batch Records, Logbooks, QC Method packets, and posted materials.
• Create Production Labels using Loftware Software.
• Coordinate document and record availability for clients.
• Maintain site licensure documentation and coordinate renewal routing.
• Lead behind-the-scenes activities for client and health authority inspections, including maintaining documents, records, and other logistics in a state of continual inspection readiness.
• Provide technical writing and information design support in document authoring and document hierarchy decision-making.
• Provide technical support and tips and tricks to internal customers for Microsoft Word and Excel.
• Troubleshoot electronic document and training management systems issues for internal customers.
• Support INCOG customers with the locating and routing of documentation and records.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level