Technical writer

2 weeks ago

Bothell, United States Synectics Inc Full time
Job DescriptionJob Description

Job Description:

  • The Manufacturing (MFG) Tech Writer supports the implementation of Enterprise Resource Programs for Manufacturing Operations at the 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.

  • Support the implementation of the eMES Enterprise Resource Program and development and integration of Syncade MES

  • 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.

Qualifications

  • Bachelor's degree or equivalent combination of education and experience

  • 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

  • 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.).

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

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