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Documentation Coordinator

Xeris Pharmaceuticals – San Diego, CA

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Overview

The Quality Assurance Documentation Coordinator will be responsible for the execution of day-to-day quality project management activities related to the company-wide Document Management System (DMS) and Quality Management System (QMS).

Responsibilities

  • Manage central filing system
  • Provide Business Administrator support for electronic Quality Systems
  • Issue controlled documents to various departments
  • Process SOP updates and review content to assist QA management approval
  • Support and provide ideas for continuous improvement
  • Work closely with manufacturing personnel to meet the needs of operations
  • Ensure good manufacturing and documentation practices
  • Work with Training Manager to compile training files for new employees, maintain training status of employees, and perform routine review of training compliance information
  • Manage documentation of change control, supplier and material qualification support, and GMP inventory control

Qualifications

  • High School Diploma required, Associates degree preferred
  • 1-2 years of experience maintaining documents within a QC or GMP/ISO-certified environment
  • Knowledge of GMPs, documentation processes/requirements
  • Knowledge of current office software (e.g., Microsoft Office)
  • Experience in electronic control systems (e.g., Veeva, MasterControl, ZenQMS)
  • Good verbal and written communication skills
  • Proficient with use of Microsoft Word, PDF Pro software, and Excel. Ability to create forms in Word, PDF Pro, and Excel, including controlled forms, as needed
  • Ability to work independently as well as in a team

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