What are the responsibilities and job description for the Document Control Clerk position at Tegra Medical?
Job Summary
The Document Control Clerk assists the Document Control team in maintaining the Document Control system which involves creation, issuance, storage, access and distribution of all documents that support the Quality Management System, following all GDP rules and ISO 13485 and FDA requirements.
Role and Responsibilities
Help support the document change process and applicable databases.
Maintain Quality document revision levels.
Assist with the Change Control process gathering jobs from the production area and making changes per the Change Request.
Support and facilitate Device History Records (DHR) documentation control including sending and retrieving records to the off-site storage facility.
Assist in maintaining the integrity of the Customer DHR's by ensuring completeness of the essential records, good document practices are followed, and verifying the proper document sign-offs.
Perform job certification process on Production and QWT job shipments/Franklin with the document control specialists.
Assist with maintaining Employee Training requirements in Unipoint database.
Assist in ensuring completeness of the storage, revision, integrity of the record and proper approval for all Quality documents and records.
Other duties as assigned
Level of Skill, Education and Experience
High school diploma or equivalent
Organized, attention to detail, Microsoft Office skills
