Allentown-Bethlehem-Easton Area, PA
Responsible for designing, developing, and updating required technical documentation.
Strong knowledge of word processing software, strong writing and analytical skills to document software capabilities
Tracking and reviewing change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory agencies
1. Review current documents- incorporate comments from Manager
2. Navigate through company Geode or similar documentation system utilizing current templates
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
6. Complete Annual Audit Trail for QA and process development Shop Floor Data
7. Experience in technical writing in validation environment.
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 the necessary information required.
Must be proficient in a documentation management system (Geode preferred) 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 proactive in resolving issues
Excellent Verbal and written communication skills. Ability to work in a team environment.
College graduate preferred.