Nanotherapeutics

Your Biopharmaceutical Development and Manufacturing Partner

Quality Systems Specialist

The QS Specialist is responsible for providing clerical and advanced software administrative support related to documentation/quality system requirements/maintenance. The QS Specialist reports to the QS Manager and will be responsible for: 

  • Auditing of documentation manuals to assure they are accurate and up-to-date, and available to appropriate personnel 
  • Maintaining filing of all master documents and assisting in all archiving activities 
  • Advanced administration of the electronic Quality Management Systems (eQMS) and electronic Documentations Systems (eDMS)
  • Assisting in the development and implementation of eQMS and eDMS 
  • Assisting in the configuration and management of the eQMS and eDMS 
  • Control and issuance of documents
  • Assisting employees with document and Quality Systems (QS) record preparation
  • Maintaining databases and generating reports
  • Authoring SOPs related to the eQMS and eDMS
  • Training users on the eQMS and eDMS System

The position requires extensive interaction with employees throughout the organization.

Minimum Education Requirements for Competency:

  • Bachelor’s degree or equivalent in education and experience
  • 2 to 10 years related experience in FDA regulated industry (depending if I, II, or III)
  • Experience with software validation
  • Good communication and organization skills
  • Must have excellent attention to detail
  • Excellent computer skills including MS Word, Excel, Access, PowerPoint or equivalent
  • Experience with eQMS and eDMS systems such as TrackWise, NextDocs or similar systems preferred
  • Experience with SharePoint software administration preferred
  • Strong written and oral communication skills

This position will be based in Alachua, FL.

To apply submit your resume to careers@nanotherapeutics.com with the position in the subject line.

Nanotherapeutics is an equal employment opportunity for all without regard to race, color, religion, sex, age, national origin, disability, or any other characteristic protected by applicable law. If you need assistance in applying for a position, please contact us through careers@nanotherapeutics.com or call 386-462-9663.

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