Document Control Specialist
4 weeks ago
This position is responsible for maintaining control of all quality documentation. The ideal candidate will work independently, with minimal supervision, in accomplishing daily tasks and advising others. This role trains others in the use of document control software, and works closely with all departments to maintain a compliant program. The 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.
Key Responsibilities
Assist with maintenance and continual improvements of the document control process.
Assist with creating, editing, and proofreading documents.
Responsible for control of documents issued to TE, TC, and other Terumo affiliates.
Processes engineering change order using software systems; including TMSWeb and JDE.
Revises documents, routes documents for approval, issues approved documents and distributes as required.
Assist with training management and employees in documentation control and change management.
Assist with maintenance of Document Center Metrics regarding document activity and status.
Assist and works on NCRs as needed regarding Document Center issues.
Serves on TMC multi-functional quality system improvement teams, particularly for initiatives related to document control.
Requirements
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
Entry level position that requires an Associates Degree, 4-year degree preferred.
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