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Technical Writer

  1. East Coast
  1. Contract
  1. Compliance / Quality Assurance
Date Posted11 Sep 2020
Technical Writer

One of our major pharmaceutical clients located on the East Coast of the US have been nominated by the government to develop and manufacture COVID 19 Vaccines. As a result, they are involved in a significant facility expansion and are looking to increase the size of their team.

Who are we looking for?

We are looking for an experienced Technical Writer to review, author and approve batch records, specification and other technical documentation. Development and implementation of processes and procedures in support of QA functions (document control, CAPA, product releases). Plan, develop, review, write and approve SOPs for all functional areas as needed.

The ideal candidate will have:
  • BA/BS in related field required and/or a minimum 5 - 8 years of proven experience writing standard operating procedures, work instructions, production batch records
  • 5 years of experience in biologics, pharmaceutical, or medical device environment
  • Candidate must possess in-depth understanding of good documentation practices in a GxP environment
  • High degree of customer focus, interdependent partnering, initiative, innovation, team work
  • Demonstrated ability to manage complexity and handle/prioritize multiple tasks
  • Knowledgeable of FDA regulations, and FDA and ICH guidance documents
  • High proficiency in procedure development and a thorough understanding of technical writing
For more information on this project / position, please apply with a copy of your up to date CV today! 

The candidate must have the rights to work in the location stated in the job advert.

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