Document Control Quality Specialist in Elmwood, Wisconsin at MAI Animal Health-Genesis
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Job Description
Job Overview:
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.
Essential Functions:
- 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.
Requirements / Skills:
- 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.
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to perform regular bending, twisting, reaching, and lifting for filing and shelving purposes.
- Must be able to occasionally lift, carry, push, and/or pull up to 30 pounds.
- Must be able to walk frequently throughout the duration of the shift.
Mark Anderson Companies is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristic.
This job description is not intended to be all-inclusive. The employee may perform other related duties as necessary to meet the ongoing needs of the organization. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Monday - Friday
6am - 2pm