Technical Writer Job at Cynet Systems in Bothell

We are looking for Technical Writer for our client in Bothell, WA

Job Title: Technical Writer

Job Location: Bothell, WA

Job Type: Contract

Job Description:

Pay Range: $44.39hr - $54.16hr

Responsibilities:

• Support the implementation of the eMES Enterprise Resource Program and development and integration of Syncade MES at the Bothell site.
• 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.

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.