Document Ctrl Coordinator

Title: Document Control Coordinator
Location: On-site in Morristown, TN

Shift: M-F Days

ESSENTIAL ACCOUNTABILITIES:

* Evaluate, develop, update and maintain quality policies and procedures in accordance with industry standards and regulations, Global policies, Iatric Policies, and best practices.
* Maintain and Control the Master Document Log.
* Assist with the compiling of the customer Annual Product Review (APR).
* Review and publish internal standard operating procedures with or without input from team members and/or Subject Matter Experts.
* Oversee the updates, revisions, and routing of policies, procedures, work instructions and forms.
* Maintains and executes electronic document control system to track and record approvals, amendments, and completion of documents changes.
* Identify, lead or manage quality system improvements associated with document control and quality record keeping focus on effectiveness, efficiency and simplification.
* Participate as an internal auditor for multiple areas and responsibilities across the plant.
* Participate in department meetings and perform other tasks and related duties as assigned by the Quality Systems Manager.
* Work cross-functionally to coordinate and support the establishment and communication of processes within and outside the department to drive consistent product Quality and on-going product Compliance.
* Manages review and routing of external documents received from external customers, routing for SME review and assimilation into current Iatric document practices.
* Communicate changes to external customers of internal document changes, as required.
* Work cross-functionally to coordinate and support the establishment and communication of processes within and outside the department to drive document control
*Demonstrate commitment to the company's RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.
*Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associate's essential accountabilities.
*Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested.

QUALIFICATION REQUIREMENTS:

*Minimum of an associate degree is required.
*3 or more years of experience required in one or more of the following functions: document management, change control in a cGMP environment, creation and/or revision of procedures and work instructions, periodic review of documentation.
*Equivalent combination of education and experience may be considered.
*Computer proficiency in Microsoft Excel, Word, Outlook.
*Knowledge of FDA (CFR 21, Part 11) and ISO regulations (ISO 13485) is highly preferred.
*FDA audit experience is preferred.
*Experience in JDE as well as Agile PLM or SAP PLM is highly preferred.
*Strong people skills to interact with all levels within the organization.
*Must be detail oriented and organized to manage multiple projects.