Document Specialist, Vector Manufacturing (Contract)

Durham, NC

Document Specialist, Vector Manufacturing (Contract)

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach at our new facility in North Carolina’s Research Triangle.

We seek a highly-motivated and organized individual with experience working in a buyer/planner role supporting a GMP biotech/pharmaceutical operation to help build and grow our materials management organization.

The incumbent will lead the development of GMP documentation pertaining to the manufacture of a gene therapy product.  

 

 About the Role:

  • Create, modify, and maintain SOPs to be utilized in GMP manufacturing areas.  Specifically, these SOPs will be for the operation and maintenance of process equipment utilized in gene therapy manufacturing.
  • Create, modify, and maintain batch records and forms to be utilized in GMP manufacturing areas.  Specifically, these batch records will be for the manufacture of gene therapy products.
  • Create, modify, and maintain training documents (OJT’s) to be utilized in GMP manufacturing areas.  Specifically, these training documents will be to record hands on training for the manufacture of gene therapy products.
  • Manage all document workflows for manufacturing area in the Veeva document management system.
  • Collaborate with Manufacturing and Quality Assurance to develop effective document templates.
  • Work closely with Manufacturing and Quality to continually improve all aspects of operations.

About You:

  • 3+ years in a manufacturing role, with bachelor’s degree in science preferred.
  • Prior employment at a biotech or pharmaceutical company in a similar role.
  • Experience with MS Word, MS Excel, Veeva QMS, and Sharepoint systems.
  • Experience writing and modifying SOPs, Batch Records, and Training documents.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Driven and self-motivated with the ability to lead and facilitate priorities and activities across cross functional teams.
  • Agility to quickly adjust and navigate shifting priorities, demands and timelines.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
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