Document Control Coordinator II

5 days ago


Brooklyn Park, Minnesota, United States Olympus Corporation of the Americas Full time
Job Summary

We are seeking a highly skilled Document Control Coordinator II to join our Quality Assurance team at Olympus Corporation of the Americas. The successful candidate will be responsible for supporting the coordination and processing of documentation changes, ensuring compliance with regulatory requirements and company policies.

Key Responsibilities
  • Support the release and change activity for new and existing products, as well as all other controlled documents.
  • Review all types of changes (ECOs, COs, IMCs, PORs, PRAs) and supporting documentation for accuracy, maintaining target turnaround times as agreed upon with the supervisor.
  • Update procedure specification type word documents as required.
  • Perform data entry into the PLM & MRP system as required (including new catalog & item numbers, bills of materials, engineering changes, and deviations).
  • Work with the Document Control team (all sites) and other departments to support quality and standardization of OSTA documentation process. Promote continuous improvement initiatives (how to improve quality, provide better customer service, reduce costs).
  • Partner with the Supply Chain Operations Analyst to project manage OSTA POR requirements.
  • Schedule and chair meetings on POR progress, publish status reports on the process.
  • Work with all departments involved to resolve issues. Thorough documentation of the issues and the resolutions are required.
  • Create POR COs and release to Site Doc Control for processing, after receiving an approved POR, within the established time target.
  • Train employees new to the POR process as required to meet OSTA business requirements.
  • Provide cross-functional support to meet business needs as required.
  • When Technical Editing needs assistance, provide short-term support when Doc Control workload will allow.
  • Function as an ERP, MRP, PLM expert.
  • Provide user support on Agile and Oracle; provide training as required.
  • Provide OSTA employee support on meeting Good Documentation Practices based on OSTA QSR documents, ISO 13485, FDA 21 CFR 820.
  • Meet deliverable, support, and quality targets as established during yearly PED objectives.
Requirements
  • High school diploma or equivalent is required.
  • Minimum of 3 to 5 years related Document Control experience in a manufacturing environment.
  • Understanding of Quality Change Management Process.
  • FDA and ISO experience.
  • Experience with MRP ERP PLM Systems.
  • Drafting, Configuration Management training or certifications are preferred.
  • Excellent writing and communication skills. Ability to read, understand, and apply information from published process documents.
  • Strong office skills: MS office: Word, Excel, Access; data entry, scanning documents, filing.
  • Team Player, interfacing well with others.
  • Extreme attention to detail and the ability to perform detail checking for long periods of time.
  • Work independently and part of a team.


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