Technical writer Job details Posted 07 February 2024 Location Bothell, WA Job type Permanent Reference 907470 Job description Title- Technical Writer Duration- 12+ months Location- Bothell, WA Pay range- $50.00 to $54.00/hr Location: 100% Onsite Role in Bothell, Washington TOP SKILLS: * 1-2+ years managing GMP Documents * 1-2+ years of MS Office 365 * 1+ years working in quality systems or project work Position Summary The Manufacturing (MFG) Tech Writer supports Manufacturing Operations by managing document revision workflows, including the document change control process as well as review and approval of documents within the document management system. Duties/Responsibilities Primary responsibilities include: * Managing document revision workflows in an electronic document management system for Manufacturing, which includes reviewing and approving document change requests, editing documents and incorporating SME input. * May own and revise Manufacturing procedures including participating on project teams as a key stakeholder. * Collaborate with Quality Systems record owners to complete change and CAPA action deliverables. * Follow Policies, SOPs, and work instructions to support the document revision process. * Track in flight document workflows and provide status updates as required. * Support internal and external audits and regulatory inspections if required. Assist with document retrieval /organization support during regulatory inspections. * Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders. Qualifications Education: Bachelor's degree or equivalent combination of education and experience Experience Basic Qualifications: * Minimum of 1 year of relevant document management in a cGMP/FDA regulated environment. * Strong communication and customer service skills. * Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles. * Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System) * Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement. * Able to prioritize, manage time well, multi-task, and troubleshoot effectively. * Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables. * Possess project management skills. * Experience interacting with FDA or other regulatory agencies preferred. * Knowledge of cGMPs and regulatory requirements. * Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.). * Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network. Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without rega