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Document Control Specialist, Quality Assurance

Document Control Specialist, Quality Assurance

1.Job Summary

  • This position is responsible for managing company documents while ensuring data integrity and compliance to company record retention policies. Will safeguard and ensure accessibility of company information. Will work with document owners, reviewers and approvers to move documents through the appropriate workflow.

2. Job Details

  • Store, manage, and track company documents using document control software, networked drive system and paper filing systems.
  • Serves as a local system administrator for the Veeva QualityDocs.
  • Monitors the document edit, review, and approval process with the document owner, reviewers and approvers to ensure that documents move through the appropriate workflow in a timely manner.
  • Reviews document meta data for completeness and accuracy.
  • Finalizes working documents and notifies employees of training requirements.
  • Supports and trains employees on Veeva QualityDocs, records management procedures and policies.
  • Scans, images, organizes, and maintains documents, adhering to the company’s document lifecycle procedures.
  • Maintains records in accordance with the records retention schedule.
  • This position reports directly to the Quality Assurance Manager.

3. Candidate Requirements

  • Associate degree or bachelor’s degree.
  • 2 – 3 years document control experience in an FDA regulated environment.
  • Experienced with document control software.
  • Computer-savvy and well-versed in Microsoft Office products: SharePoint, MS Word, Adobe Acrobat.
  • Detail-oriented, dependable and trustworthy.
  • Strong interpersonal, communication and customer service skills.
  • Strong organizational skills.
  • Self-directed and able to work independently.
  • Highly motivated and able to work in a deadline driven environment.
  • Strong time management skills.
  • Ability to troubleshoot and problem solve.
  • Fluent in English (oral and written).
  • Job Type: Full-time.
  • Salary: $55,000.00 to $75,000.00 /year

To Apply

Send your resume and message to pkilbourn@elevartherapeutics.com.