Document Control Quality Specialist

MAI Animal Health-GenesisElmwood, WI
Onsite

About The Position

The Quality Documentation Specialist is responsible for managing, reviewing, coordinating, and maintaining quality system documentation associated with Engineering Change Requests (ECRs) and Engineering Change Notifications (ECNs). This role serves as a key liaison between Quality, Engineering, Manufacturing, and Operations teams to ensure all product, process, tooling, and documentation changes are properly documented, reviewed, approved, communicated, and implemented in accordance with company procedures, customer requirements, and applicable regulatory standards. Additionally, this role is responsible for creating, updating, and maintaining Standard Operating Procedures (SOPs) and related documentation for MAI/Genesis and Genesis Industries.

Requirements

  • High School diploma or equivalent required.
  • Minimum of one year of administrative experience preferred.
  • 2–5 years of experience in document control, quality systems, engineering support, or change management.
  • Self-starter with the ability to work independently and cohesively with others.
  • Excellent verbal, written, interpersonal, and computer skills.
  • Meticulous data entry skills and strong attention to detail.
  • Ability to review, interpret, and evaluate company documents.
  • Ability to work in a fast-paced environment, meet deadlines, and perform under pressure.
  • Ability to work in a team environment while maintaining a professional disposition.
  • Proficient in Microsoft Outlook, Word, and Excel.
  • Proficient in Quality Management System software (QT9) preferred.

Nice To Haves

  • Proficient in Quality Management System software (QT9) preferred.

Responsibilities

  • Coordinate and administer Engineering Change Requests (ECRs) and Engineering Change Notifications (ECNs) through the established change control process.
  • Review change requests for completeness, accuracy, technical documentation requirements, and compliance with company procedures.
  • Review and manage daily emails related to QT9 tasks, production updates, and documentation requests.
  • Maintain accurate records of all engineering changes and ensure complete traceability from initiation through implementation.
  • Create, revise, issue, and inactivate SOP documents as needed.
  • Manage priorities including, but not limited to, change controls, projects, new SOP creation, five-year SOP reviews, and current SOP updates.
  • Maintain a presence on the production floor to review SOP compliance and gather updates from operators.
  • Schedule and coordinate SOP pre-review meetings.
  • Collaborate with Production, Quality Control, Regulatory, and Supervisory teams to support testing, risk assessments, and documentation updates.
  • Review notes, samples, history, and documentation for accuracy.
  • Maintain proper document control and revision management.
  • Perform other duties as assigned.
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