Document Controller

QA Document Control Specialist

Location: RTP

Duration: Minimum 6 months likely extension

The Document Controller is responsible for electronic documentation and records management oversight at the Concord site. This role is responsible for execution, maintenance, and administration of document management systems. The Document Controller will aid in initial program startup and routine operation of the site, as well as support site inspection readiness and execution.

Key Objectives/Deliverables:

• Maintain GMP Library document inventory control through the our clients Record Manager (LRM) system, as required.
• Maintain Doc Controller role for all documents and records maintained in Veeva Quality Docs Electronic Data Management System (EDMS).
• Ensure client training and compliance to global and local Documentation and Records Management requirements.
• Assists in support of processes for updating, routing, and approval of electronic documents by appropriate client personnel.
• Day to day management and monitoring of assigned Veeva Vault QualityDocs workflows.
• Meet with internal personnel to review documents and assign Veeva Quality Docs meta data when adding documents into the Veeva Quality Docs EDMS.
• Manage Retention of GMP Related Records in accordance with Document Type and Record Class Codes (RCC). This includes shipment of GMP records to External storage location for long term retention as necessary.
• Manage and facilitate reconciliation process for executable records.
• Support external and internal audits through providing readily accessible records as requested for review by Regulatory Agency and Notified bodies, and/or internal auditing and compliance groups.
• Support Site Self Inspections associated with Document Control and the Veeva Vault Q Docs Electronic Data Management System (EDMS).
• Monitor and ensure that document periodic reviews are performed within Veeva Vault QualityDoc according to client standards.
• Follow up with document owners to ensure review and updating on a timely basis
• Work closely with Quality, Learning and Development, and other functions to ensure their document needs are captured as required.

Basic Qualifications

• Education: High School Diploma or equivalent
• Experience:
• Three years previous document management experience.
• Previous experience working in a regulated environment.

Additional Skills/Preferences:

• Experience with Microsoft Office (Outlook, Work, & Excel)
• Previous experience in records management, data entry, or similar experience
• Demonstrated ability to work successfully in a team environment
• Demonstrated Project Management skills
• Strong written and verbal communication skills
• Strong ability to solve problems and make decisions
• Experience with documentation in a GMP environment and electronic tracking of document
  • Experience in quality systems such as TrackWise, Veeva Vault QualityDocs

Additional Information:

• Ability to work 8-hour days – Monday through Friday Day shift; Onsite
• Some overtime may be required to support audits as necessary