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Technical Writer

Company: FUJIFILM
Location: Santa Ana
Posted on: May 3, 2021

Job Description:

Fujifilm Irvine Scientific, a member of Fujifilm Holdings Corporation, is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large- scale production of biotherapeutics and vaccines. Fujifilm Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 45 years, Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.

 

We are hiring a Technical Writer for our Document Control and Operational Excellence group. The Technical Writer will be responsible for the preparation and review of protocols, reports, procedures, training materials and other documents for multiple departments at FUJIFILM Irvine Scientific. The person in this role will create, develop, plan, write and edit operational, instructional, maintenance and test procedures.

 

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Responsibilities:

  • Conduct interviews with various users and technical staff to gather data for documentation
  • Research and translate technical information into documents for nontechnical and technical users
  • Recommend formats responsive to technical and customer requirements
  • Perform quality control (QC) checks of draft documents to ensure the accuracy of the data and resulting subsequent conclusions
  • Review documents for style, clarity, grammar, and punctuation
  • Produce products that conform to the company documentation and quality assurance standards

Experience/ Education:

  • Bachelor’s degree required
  • At least 4 years of relevant experience in a Medical Device or Pharmaceutical organization
  • Knowledge of current industry regulations, e.g. cGMP, ISO 13485, 21 CFR Part 820, TGA and Canadian Medical Device Regulations strongly preferred
  • Experience writing software instructions or validation documents a plus
  • Computer skills, specifically MS Word, Excel, Gmail
  • Exceptional written and verbal communication skills required

Fujifilm Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

 

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Keywords: FUJIFILM, Santa Ana , Technical Writer, Other , Santa Ana, California

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