Document Control Specialist - Fishers, United States - INCOG BioPharma Services

Description

The Document Control Specialist will be instrumental in developing and championing our new organization's approach to the design, approachability, control, and training of content, working closely with the Senior Manager of Quality Assurance, 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.

Essential Job Functions:

• 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.
• Train new employees on the requirements and significance of Good Documentation Practices and controlled document management.
• 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.
  

Special Job 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.
  

Additional Preferences:

• 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.

Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs.

Our culture and priorities are different by design:

focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you.

Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.

All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.