Manufacturing Technical Writer Pharma (Onsite, Bothell, WA)

We are seeking a Manufacturing Technical Writer for a global pharmaceutical company. The Manufacturing (MFG) Tech Writer supports the implementation of Enterprise Resource Programs for Manufacturing Operations at the client Bothell site by managing document revision workflows, including the document change control process as well as review and approval of documents within the document management system.

This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Bothell, WA.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

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.

Requirements:

• Minimum of 1 year of relevant document management in a cGMP/FDA regulated environment.
• 1+ years of MS Office 365 (e.g. Word, Adobe, Visio and Excel)
• 1+ years working in quality systems or project work (e.g. Document Management System, Quality Management System)
• Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality principles.
• Possesses project management skills.
• Experience interacting with FDA or other regulatory agencies preferred.
• Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
• Bachelor's degree or equivalent combination of education and experience

Please submit your resume to our network at (please apply to the Manufacturing Technical Writer Pharma (Onsite, Bothell, WA) role).