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GMP document writer

  1. United States
Seattle
  1. Contract
Competitive
  1. Life Sciences
04-04-2024
33484
GMP document writer - Pharma - Seattle, USA - 12-Month Contract 

Our client, a global biotechnology organization, is recruiting for a GMP document writer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a GMP document writer to help expand our client's biotech operations throughout Europe. As the GMP document writer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.


Responsibilities:

  • The GMP document writer will support an expansion project by writing all the documentation to ensure all is ready for execution.
  • This will include SOPs, protocols, validation plans and all supporting documentation for the expansion project.
  • The Specialist collaborates with subject matter professionals and technical specialists to plan, develop, author, edit format illustrate, update, and build new standard operating procedures and other related documentation such as PBRs, logbooks, Job aids and technical reports in support of the GMP manufacturing facility.
  • Responsibilities include maintaining established documentation design and quality standards using performance tools and leading documentation workflows to meet departmental needs.

Requirements:
  • Experience writing GMP documentation including SOPs, protocols, DQ, IQ, OQ, PQ etc.
  • Experience working with a life sciences industry for minimum 5 years.
  • Experience executing the documentation would be a plus.
  • Ability to work with all levels of people.

If this role is of interest to you, please apply now! 

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