Cynet Systems
Cynet Systems is hiring: Technical Writer in Bothell
Cynet Systems, Bothell, WA, United States, 98021
Job Description
Job DescriptionCompany Description
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.
visit our career site to see all open positions @ http://jobs.cynetsystems.com
Company Description
visit our career site to see all open positions @ http://jobs.cynetsystems.com