Position Title: Documentation Coordinator
Reports to: Quality Manager
Supports Preco’s Data and Change Management processes by coordinating, preparing and submitting documents in compliance with internal and regulatory processes for customers, regulatory agencies, and other departments. Responsible for supporting creation and editing of quality documents ensuring the accuracy of the quality systems regarding regulatory, customer and certification standards. Support other quality functions for on-site CMS and LED manufacturing as needed for administrative needs as directed by the Quality Manager. This position reports to the Manager of Quality and Food Safety.
- Maintain the integrity, and organization of the document control program.
- Obtain documents from project resources (Manufacturing and Quality Engineering, CMS and LED Manufacturing, Purchasing, Materials Group, etc.) and update documents as needed to adhere to mandatory document formatting for entry into document management system.
- Initiate and track document workflows into the document management system and ensure consistency and accuracy.
- Incorporate comments and formatting necessary during the document review process. Assist with writing documentation, including processing red-line documents.
- Maintain all change logs and master document indexes in our document control system.
- Coordinate and execute customer document requests of quality system and topics as defined by the Quality Manager.
- Maintain, document, and communicate customer special requirements and expectations as directed.
- Provide guidance to the facility on regulatory issues for local, state, and federal agencies. Works in cooperation with the QA team and other departments to address and assist in resolving documentation editing and compliance issues.
- Be proficient in and follow all Safety Programs, Good Manufacturing Practices (GMPs), Company Policies and Procedures and HACCP Programs as well as overall compliance for a food manufacturing environment.
- Assist with compiling and communication of qualitative and quantitative findings from QA department testing, etc. as needed.
- Assist Quality Manager with data management of Plant and Departmental Metrics.
- Help support the Internal Quality Auditing process which may include scheduling audits per the Audit Schedule, preparing audit materials, ensuring compliance to quality records requirements.
- Perform additional tasks and duties as assigned
- 2 year technical or business degree, or equivalent experience
- Strong working knowledge and understanding of the ISO 9001:2015
- Knowledge of ISO 13485:2016 Quality Management Systems and SQF Code (preferred)
- Advanced proficiency with Microsoft Office
- Experience with working with ERP/MRP Systems
- Ability to critically think and solve problems
- Demonstrates the willingness to learn as part of the organization’s continuous improvement process.
- Ability to organize, manage multiple priorities, and maintain high attention to detail in a fast-paced environment
- Strong technical writing, written and verbal communication skills
- Have a professional demeaner, exhibiting an ability to communicate with a wide range of individuals
All Preco, Inc. employees are empowered to stop production and notify their supervisor/manager if an unsafe act or product quality concern is occurring. Also, each member of the Preco – Somerset team is responsible for identifying continuous improvement opportunities and participating in problem-solving teams as necessary.
Send resume to: email@example.com
This position is located in Somerset, WI