Location: Pearl River,NY, USA
Research, write, and edit technical documents such as standard operating procedures, change controls, protocols and deviations.
2. Work closely with manufacturing, validation and quality team to ensure accuracy and completeness of documentation
3. Provide summary reports to management and project team on the status of documentation activities
4. Ensure compliance with industry standards and regulations
Navigate Microsoft Word independently. They should also be familiar with Excel. Experience with Veeva Vault/Qualipso is requried.
1st Shift: Responsible for designing, developing, and updating required technical documentation. Responsible for technical writing/editing for all types of documentation produced within a modern software development environment. Utilize knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality. Document programming standards and procedures. Track and review change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with regulatory requirements. Must be able to work quickly with a high degree of accuracy. Must possess sound interpersonal and information gathering skills, be 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. Navigate through client EDoc (Documentum) system utilizing current templates. Notify manager of workflow status and issues. Incorporate comments from team members and provide status to manager on review and approval workflow. Follow up with team members on comments. Skills: Technical writing abilities and good time management. Strong root cause analysis skills with experience regarding quality standards. 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 EDoc 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. Education: University graduate preferred. Secondary Education diploma a requirement.. Years of Experience: 0 - 3 Years