Technical Writer Job at ASK Consulting LLC in Bothell

"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title: Technical Writer

Location: Bothell, WA 98021

Duration: 12 months

Pay Range: $44.39-$54.16/Hr

Job Description:

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 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.

Qualifications:

Education: Bachelors 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.

The starting hourly compensation for this assignment is a range from $44.39 - $54.16. While the final, individual compensation will be determined by your employer of record, factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed. The starting hourly compensation may be subject to change.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.