Prepares, revises and routes documentation in compliance with regulations and standards. Coordinates the required activities needed to place and maintain documents under CN control. Creates, implements and maintains systems and procedures to ensure a well-developed, standardized and consistent process for documents and records. Provides direction to department support staff that provides support to this process. Maintains system documentation and respective department policies, ensures quality compliance. Interface with originators, process facilitators and approves to ensure the entire process is followed as functional boundaries are crossed.
Will serve as a back up to Kit Documentation specialist position which includes duties as described above as well as shipping and receiving responsibilities and handling of instrumentation.
- Data Entry, Alpha & Numeric MS Word
- Advanced Excel Experience is REQUIRED for this position
- Organizational skills
- Strong written and verbal communication skills
- Database or ERP systems-such as Access or SAP
- Document Control
- Must be able to lift up to 35 pounds and occasionally stand for up to 6 hours per day
- Sequel Reports
- Calibration management system such as Blue Mountain Regulatory Asset Management System or CalMan
- Logistics - raw material or product shipping, handling and/or management of supplies or bills of material
- Minimum of an Associate's degree