Document Control Specialist

Job Summary

This Document Center associate is the expert in maintaining control of all quality documentation.  This position works independently, with minimal supervision, in accomplishing daily tasks and advising others.  This position trains others in the use of document control software, and works closely with all departments to maintain a compliant program.  This position is responsible for organizing, maintaining, and updating all controlled documents.  All functions of the document center must be in compliance with quality system GMP and ISO standards.

Job Details/Responsibilities

1.    Responsible to follow requirements of applicable national and international regulations.
2.    Assists with maintenance and continual improvements of the document control process.
3.    Assists with creating, editing, and proofreading documents.
4.    Responsible for control of documents issued to TE, TC, and other Terumo affiliates.
5.    Processes engineering change order using software systems; including TMSWeb and JDE.
6.    Revises documents, routes documents for approval, issues approved documents and distributes as required.
7.    Assists with training management and employees in documentation control and change management.
8.    Assists with maintenance of Document Center Metrics regarding document activity and status.
9.    Assists and works on NCRs as needed regarding Document Center issues.
10.    Serves on TMC multi-functional quality system improvement teams, particularly for initiatives related to document control.
11.    Associate participates in project performance team meetings on behalf of the job unit in order to provide ideas, methods, or processes for unit/company performance improvement.
12.    Performs other job related duties as assigned. 

Knowledge, Skills and Abilities (KSA)

• Strong computer knowledge (MS Office) and technical writing skills. 
• Ability to clearly communicate, both verbal and written.  Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail due to demand for accuracy in controlled documents. 
• Must have demonstrated initiative and ability to work independently while handling multiple tasks. 
• Good theoretical knowledge with ISO standards (EN 13485, EN 15223)/regulatory requirements (21 CFR 820 and related labeling regulations). 
• Strong organizational skills, attention to detail and ability to handle multiple tasks. 
• Knowledge of manufacturing helpful.    

Qualifications/ Background Experiences

• Entry level position that requires an Associates Degree, 4-year degree preferred.