The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Technical Writer in Bothell, WA.

Role Description

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.

Skills & Requirements

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 client 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.

*Qualifications*

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. 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.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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