Primary Role:

The Quality Document Control Specialist is responsible for oversight of Document Control and record retention of all functional areas at Myonex for the Quality department. The role will focus on compliance to all applicable government regulations and compliance with company policies and procedures.

Duties:

• Provide efficient and reliable support services within the Quality department with responsibilities including and not limited to, coordinating all aspects of document control activities and global record retention program
• Conduct general document management activities such as review prior to filing to ensure GxP compliance
• Responsible for scanning, filing, and maintaining GxP documentation physically and electronically, as required, where electronic records are not currently utilized. This may include validation and qualification documentation
• Maintain the Document Storage Room, including and not limited to, organizing the filing area, inventory management, ensuring cleanliness and document accessibility to ensure all documents are retrievable in a timely manner in accordance with governing procedures
• Manage the oversight for documented flow of controlled documentation for the Document Storage Room
• Assist with monitoring record retention schedule to ensure documents are prepared for further processing (i.e., record destruction) in accordance with client Quality Technical Agreements (QTAs) and governing procedures
• Perform day to day tasks and ongoing projects related to the Document Storage Room to support the Quality department
• Assist with Audit activities including and not limited to audit preparedness, generating indices and reports, note-taking, collection of requested documents and supporting the Auditor for any other tasks as may be required.
• Oversee generation, issuance, closure, and tracking of site logbooks for all applicable departments
• Oversee the usage of Myonex document templates supporting all business divisions and operations where eQMS options are not currently available
• Supporting self-inspections as an auditee team member as pertains to Document Control and Record Retention
• Maintain trackers (i.e., Excel databases) for tracking and monitoring of Quality reports and issuance of document numbers for paper-based systems manually as needed and in eQMS as available
• Administrative support with electronic Management System (eQMS) for training, controlled documentation, audits/supplier management, and QMS reporting. Any other duties commensurate with this role
• Any other duties or tasks related to GxP as instructed by the senior members of the Quality team
• Embody the Myonex Core Values:
• Be a Great Team Player
• Be Customer Focused
• Learn & Grow
• Find a Way

Experience and Skills:

Education & Experience:

• BA/BS degree in related field or Associate degree with equivalent experience.
• At least 2 (two) years of relevant experience, preferably, in an FDA regulated environment.
• General knowledge of FDA requirements as relates to document control and record retention.

Skills/Qualifications:

• Microsoft Office
• Detail-oriented and organized with ability to multi-task
• Time Management Skills