We are seeking a Quality professional to be the primary supportive role in the maintenance of document and record issuance, flow, and reconciliation. The Technician will provide support to all internal customers on the distribution, circulation, and receipt of paper records. The Technician will also work with external clients on access to record repositories and client record distribution. Organization and upkeep of the records archives and preparation of records for physical relocation will also be a primary job function. The Technician will also troubleshoot issues with, and provide guidance on, Good Documentation Practices and word processing/document design for internal customers. A passion for internal customer service and knowledge management will make the Technician a key member of the growing INCOG organization.

Working closely with the Document Control Specialist, the Technician will be instrumental in providing internal and external customer needs for the issuance, control, reconciliation, archival and shipment of paper records, the creation and review of electronic records, and the create and editing of primary master documents. The Technician will also play a primary role in the paper goods and office supplies management, and client and regulatory audit logistics.

The Technician 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 Technician 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 Technician 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 Technician 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.

Key Responsibilities:

• Supporting the routing, review, release, and retirement of controlled documents in an electronic document management system.
• Providing document editors with word processing and document structure support.
• Issuing, controlling, and reconciling Batch Records, Logbooks, and Controlled/Distributed Copies.
• Scanning of paper records and conversion to electronic records.
• Upkeep and organization of a paper record archive.
• Packaging of records and arrangement of off-site storage.
• Management of paper goods and office supplies.
• Support of records movements and supply logistics for client and regulatory audits.
• Troubleshooting and supporting internal clients with Good Documentation Practice needs.

Minimum Qualifications

• High school diploma or equivalency required.
• Minimum of 2 years’ experience in a role requiring a high-level of organization and internal and/or external customer support and service.
• Exceptional computer skills, particularly moderate-level experience with Microsoft Word or equivalent word processing.
• Excellent verbal and written communication skills, and familiarity with workplace communication standards.
• Able to lift and move boxes of up to 50lbs and stand for moderate periods of time.

Preferred Qualifications

• 2 years’ experience in a role requiring and/or supporting word processing, and document authoring or design.
• 3 years’ experience with office machine or industrial printing and scanning technology.
• Moderate Microsoft Office Beginner or Intermediate certification in Word and/or Excel.
• Experience with Microsoft PowerPoint, Visio and/or other presentation software packages.
• Experience as a user of electronic business systems or processes.

At INCOG BioPharma we are building 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.We are building our team with people who lead by example and drive the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement.We are in the process of constructing the GMP facility and organization from the ground-up, which gives us the opportunity to leverage the knowledge we’ve gained over our careers to “do it right” in 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.