Allentown-Bethlehem-Easton Metro Area, PA
Responsible for designing, developing, and updating required technical documentation and change controls. Responsible for technical writing/editing for all types of documentation produced within a modern software development environment. Initiate change controls in the electronic quality system (PHENIX) and track progression through assessment and approvals. Update process of action items and close-out as completed by technical owners. Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality. Documents programming standards and procedures. Experience: 2 to 4 years.
Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others
Review current documents- incorporate comments from Manager
2. Navigate through electronic systems for documents and change controls. (E Doc (Documentum) system utilizing current templates for protocols and reports. PHENIX for change controls).
3. Notify manager of workflow status and issues
4. Incorporate comments from team members and provide status to manager on review and approval workflow.
5. Follow up with team members on comments
Technical writing abilities and good time management. Strong root cause analysis skills with cGMP experience. To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
Must be proficient in E Doc with a working knowledge of templates, workflows and approval process
Proficient in MS Word, Excel, Powerpoint and Outlook
Interact well with a diverse group of individuals
Self motivated and willing to be pro active in resolving issues
Excellent Verbal and written communication skills. Ability to work in a team environment.