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Document Control Specialist

4 months ago

Cambridge, United States Randstad Life Sciences US Full time

Technical Writer

Duration: 1 year contract

Location: Onsite in Cambridge, MA - flexibility to work 1 day from home

Hours: Monday through Friday


Description:

  • The technical writer position will require interaction with manufacturing personnel, manufacturing engineering managers, manufacturing compliance, Quality assurance and Manufacturing Science and Technology (MSAT) in order to develop and improve procedures and Master Batch Records (MBR’s) for using in producing vaccines.
  • The technical writer will coordinate with manufacturing and technical personnel to create and modify SOP’s and MBR’s, manage team meetings to obtain and resolve comments, escort documents through the review and approval process.
  • Most technical input will be provided by personnel but familiarity with GMP manufacturing, Good documentation practices and significant figures is required.
  • Familiarity with biologic manufacturing processes and equipment for downstream operations and familiarity with calculations typically used in the preparation of batch records for biological products is a plus.
  • The technical writer will manage multiple documents revision requests and must have good organizations skills, and the ability to schedule and coordinate meetings and maintain a tracking spreadsheet.


Requirements:

  • 3+ years experience with MSWord, utilizing formatting.
  • 2+ years of experience revising MBRS, SOP’s and managing document reviews and approval work flows.
  • 2+ years of MS Excel
  • Self starter that can advance documents by working with other personnel without direct oversight by manager.


Preferences:

  • Experience with managing workflows in Veeva
  • Experience with SAP