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Technical Writer

Posted 5 days ago

  • Expiry Date: 12 June 2022

About Client:

  • Client is an American multinational pharmaceutical company.

  • Headquartered in New York City, Client is one of the world's largest pharmaceutical companies and consistently ranks on the Fortune 500 list of the largest U.S. corporations.

Job Description:

Onsite!

QC Raw Materials Technical Writer in Bothell, Washington.

  • We are inspired by a single vision transforming patients' lives through science.

  • In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change.

  • We bring a human touch to every treatment we pioneer. Join us and make a difference.

  • Bothell, Washington is searching for a highly organized QC Technical Writer to join our growing Quality group! As our QC

  • Technical Writer for our Bothell, Washington Quality Control group, you will work independently and be responsible for the authoring of high-quality documentation in support of QC Raw Material testing at the CAR T manufacturing facility in Bothell, Washington.

  • This includes, but is not limited to, material specifications, methods, Standard Operating Procedures (SOPs), protocols and reports.

  • Our group is looking for someone with excellent project management skills who can help organize projects and track, monitor, and drive signature approval processes for multiple in-flight documents.

This role works Monday - Friday, Day Shift

Role Responsibilities:

  • Authors and revises GMP documents.

  • Authoring new documents to support raw material testing including, but not limited to, specification authoring and Certificate of Analysis creation.

  • Revising existing documents as needed.

  • Managing the development of documents through the electronic document management system.

  • Assisting in the execution of Change Controls as needed.

  • Working with internal teams to obtain an in-depth understanding of QC processes and their documentation requirements.

  • Producing high-quality documents that meet applicable standards and are appropriate for their intended audience.

  • Writing easy to understand instructions where required.

  • Creating tutorials to help end-users train on a variety of activities.

  • Creating and maintaining documentation projects and timelines.

  • Providing excellence attention to detail when writing or revising documents.

  • Applying critical thinking skills when developing documents for new procedures.

  • Performs other tasks as assigned.

Role Requirements:

  • Bachelor's degree required, preferably in chemistry, microbiology, or related science; Advanced degree preferred.

  • An equivalent combination of education and experience will be considered.

  • At least 4 years of relevant work experience, preferably in a regulated environment.

  • Proven work experience in authoring and revising GMP documents.

  • Ability to deliver high-quality documentation while paying attention to detail.

  • Ability to quickly grasp complex technical concepts and make them easily understandable through text and pictures.

  • Excellent English writing skills.

  • Strong working knowledge of Microsoft Office.

  • Familiarity with GMP electronic documentation systems.

  • Ability to work in a highly regulated environment and to follow Good Documentation Practices (GDPs).

  • Advanced ability to work in a collaborative team environment and train others.

  • Ability to adapt to changing priorities and manage multiple assignments while meeting timelines.

  • Ability to set priorities for the group and mentor associates.

  • Strong organizational skills and critical thinking skills.

Skills:

  • Advanced Excel and/or Smartsheets is a plus!

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.