Quality Documentation Coord

Fresenius Medical CareKnoxville, TN
Onsite

About The Position

Updates logs and databases of product, manufacturing and regulatory compliance information. Coordinates the review and revision of procedures, specifications and forms. Prepares process and status reports, assigns and monitors document numbers and reviews documents for accuracy and completeness.

Requirements

  • High School Diploma required
  • 1 – 2 years’ related experience.
  • Ability to follow Quality Assurance procedures.
  • Experience using document management/records management software solutions.
  • Self-motivate/self-starter, ability to carefully review documentation.
  • Ability to be very organized with files and other documentation.
  • Must be detail-oriented and thorough.
  • Must pass a color vision screen.
  • Strong oral and written communication skills.

Responsibilities

  • Maintain the integrity of working documents and update documentation when revised.
  • Review manufacturing records.
  • Prints release documentation.
  • May refer to senior staff for assistance with higher level problems that may arise.
  • Escalates issues to supervisor for resolution, as deemed necessary.
  • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
  • Assist with various projects as assigned by direct supervisor.
  • Other duties as assigned.
  • Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
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