Electronic Document Management System Administrator

3 weeks ago

Blue Ash, Ohio, United States Aprecia Pharmaceuticals Full time

Job Summary

This position is responsible for the administration of Aprecia's electronic document management system, Master Control. The successful candidate will ensure seamless operation, maintenance, and user support of the system, while collaborating with cross-functional departments to coordinate, create, and implement processes and procedures to ensure site quality compliance requirements are being followed.

Key Responsibilities

  • Administer the electronic document management system (Master Control) to ensure seamless operation, maintenance, and user support.
  • Develop and maintain installation and configuration management procedures.
  • Execute daily user administration tasks, including creating, modifying, and disabling user accounts per approved procedures.
  • Work closely with the software provider to resolve system issues, propose enhancements, troubleshoot and resolve application issues, and test and implement additional functionality within the system.
  • Proactively follow up on Master Control support issues to provide updates and resolutions to end users.
  • Coordinate and communicate with impacted stakeholders as needed.
  • Collaborate with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
  • Investigate deviations within the Master Control system and develop comprehensive correction action plans.
  • Conduct final Quality review of GMP documentation within Master Control workflow.
  • Perform essential day-to-day administrative hands-on tasks.
  • Coordinate with process owners to deploy new modules, including developing and delivering training to process owners and users.
  • Monitor and report on key quality metrics, identifying trends and areas for improvement; includes developing reports to enable efficient real-time reporting.
  • Support regulatory, organizational, and vendor audits as needed.
  • Write and revise SOPs as necessary to ensure compliance, efficiency, and clarity.
  • Participate in quality and process improvement initiatives as well as project teams.
  • Ability to work with minimal instructions on routine work and detailed instructions on new assignments.

Requirements

  • Understanding of GMP, FDA Regulations & Guidance's (specifically 21 CFR Part 11) including industry requirements and trends toward preserving data integrity.
  • Strong analytical and problem-solving skills with meticulous attention to detail.
  • Excellent organizational and time management skills with the ability to manage multiple priorities.
  • Demonstrated capability in solution deployment and project management skills.
  • Proficiency in both written and verbal communication and presentations with the ability to work collaboratively in a team environment.
  • Demonstrated ability to effectively interact with customers of all organizational levels.
  • Proficiency in Microsoft Office Suite.

Education and Experience

  • B.S. degree in a scientific discipline or equivalent required or equivalent combination of education and experience.
  • Professional with a minimum of 3 years of experience with systems administration in a pharma, biopharma/biotech or healthcare environment preferred.
  • Familiarity and previous experience working with Master Control and/or other electronic document management system (Veeva, Documentum, Compliance Wire, etc.) preferably in a System/Document Administration capacity preferred.

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