Roche
Indianapolis, IN, USA
The Position The Document Control Specialist responsibilities include preparation, revision and route documentation with regulations and standards (e.g. Quality System Regulations, Content Approval, ISO Standards and internal guidelines). Additionally, the Document Control Specialist supports department projects and change control execution as well as performing test cases for various process changes. These changes will include process improvements, computer application modifications (e.g. database configuration, reporting tool development). Coordinates the interaction between engineering, validation, field operations, and the calibration department to ensure appropriate changes are documented. Works independently within guidelines and policies, receives minimal guidance. Acts as a resource for colleagues with less experience and provides functional guidance. Applies advanced knowledge and skills to complete assignments requiring judgement and initiative. Understands...