Technical Writer

Skills

• 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.

Description

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.

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.