The Quality System Specialist is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation.

RESPONSIBILITIES

  • Provides operational support to the Quality department through the maintenance of the Quality Management System (QMS)
  • Manage and maintain document control system and entire document lifecycle including change request issuance, format review, scanning, filing, and sending release notifications
  • Review and filing of records and other controlled documents in a timely manner (i.e. SOPs, forms, Specs, emails, supplier related documentation, etc.)
  • Assist with writing, revising & creating Standard Operating Procedures (SOPs), Internal Process Flow Charts, Certificate of Analysis, Specifications and other Quality related documentation
  • Assist internal departments in navigating procedures to ensure timely and accurate completion of change requests
  • Maintain a complete and accurate index of documents
  • Maintain a complete and accurate training log of quality department employees. Notify those responsible when periodic review of controlled documents, and training are due
  • Provide Lab support
  • Assist in the Audit process of the ISO management system
  • Assist in the development, recommendation and monitoring of corrective and preventive actions
  • Analyze data to identify areas for improvement in the QMS system
  • Departmental quality reporting as necessary to support the department
  • Assisting in other QA functions as assigned

ENVIRONMENT/PHYSICAL DEMANDS

  • Working in both a warehouse and office¬†environment
  • Very active position that requires standing, stooping, climbing, reaching, walking, stepping, kneeling and crawling
  • Time driven deadlines
  • Use of computer
  • Frequent use of math
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

REQUIREMENTS

  • 5+ years experience in quality systems, technical, or managerial document control functions
  • Experience in ISO regulated work environments preferred
  • Organizing, planning and problem solving skills a must
  • Must have a strong attention to detail
  • Proficient use in Microsoft Excel, Work, Outlook, Powerpoint, Access
  • Good statistical and numerical ability
  • Ability to perform tasks independently & in a team environment
  • Ability to complete daily tasks according to work schedule
  • Must have excellent oral and written communication skills
  • Seeks continuous improvement, adapts quickly to change, apply sound judgment

Use the form below to apply

  • Accepted file types: pdf, doc, docx.