Document Ctrl Coordinator

Rockline Industries & Iatric Manufacturing • Morristown, TN

28d • Onsite

About The Position

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.

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.
• Strong people skills to interact with all levels within the organization.
• Must be detail oriented and organized to manage multiple projects.

Nice To Haves

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree