Careers Integrated Resources Inc is hiring: Quality Technical writer in Bothell
Careers Integrated Resources Inc, Bothell, WA, United States, 98021
Job Title: Quality Technical writer
Location: Bothell, WA (100% onsite)
Duration: 12 months+
Pay Rate: $52/hr on w2
Top skills:
Minimum of 1 year of relevant document management in a cGMP/FDA regulated environment.
1-2+ years of MS Office 365
1+ years working in quality systems or project work
Position Summary
The Manufacturing (MFG) Tech Writer supports the implementation of Enterprise Resource Programs for Manufacturing Operations at the BMS 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.
Primary responsibilities include:
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.