Quality Documentation Control Specialist

ProMed Molded Products
Any Location, MN
Job Description
The Quality Assurance Document Control Specialist is responsible for day-to-day administration, maintenance, and continuous improvement of the organization’s document control within the Quality Management System (QMS) in a regulated pharmaceutical and medical device environment.

Requirements

  • Administer the operations of the document control system
  • Maintain document master lists and revision histories
  • Manage physical and/or hybrid document distribution
  • Process document change requests
  • Assign and maintain document numbering schemes
  • Ensure document templates are standardized
  • Oversee the creation, review, approval and distribution of controlled documents
  • Maintain the documentation files in compliance with ISO 13485, FDA 21 CFR 820 and 21 CFR Part 11
  • Manage electronic and physical document repositories
  • Support the periodic review process for controlled documents
  • Coordinate training assignments for new and revised documents
  • Inputs data to create and revise material and method masters in the ERP system
  • Identify and escalate gaps, inconsistencies, or potential compliance risks within the QMS
  • Participate in internal audits and self-inspections
  • Support corrective action follow-up activities
  • Support the implementation of regulatory changes and quality system improvements
  • Assist in preparing responses to audit observations or regulatory findings

Benefits

  • Generous Paid Time Off
  • 401k Matching
  • Retirement Plan
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