Lead Specialist, Document Control - Quality Assurance

Durham, NC

Fast growing gene therapy company

Join bluebird bio’s enthusiastic and collaborative Quality team by contributing to the overall success of our novel gene therapy approach.  The Document Control Specialist will support and help implement our Document Control Program in Durham, NC (bRT).   In this position, you will be responsible for supporting the implementation and maintenance of the document control system and the document archive room for the bluebirdbio manufacturing site at bRT.  Additionally, you will help develop and will maintain the bluebird bio Quality Document Control System consistent with international regulations and industry standards. This is a great opportunity to have a major impact on developing a document control system that will impact the quality culture at bluebird bio.  

About the role:

  • Support the maintenance of the document control system, including formatting, numbering, scanning records into EDMS (VeevaDocs).
  • Maintain the document control system including management of the lifecyle of paper and electronic records.
  • Review new and revised controlled documentation for appropriate format, content and consistency with other documentation and compliance to document control procedures
  • Drive improvements and efficiencies to the document workflow process, including editing workflows and document management metrics.
  • Issuance and reconciliation of logbooks, forms and batch records.
  • Support improvement initiatives to strengthen document management processes and systems.
  • Assist in development and use of document templates, standards and conventions
  • Support customers in development and use of document standards.
  • Manage the indexing and documentation for filing/archiving of paper records for easy retrieval during a regulatory inspection.
  • Issue and manage electronic records in the EDMS
  • Assist with the archival & retrieval of records to off-site document storage facility(ies)
  • Work with stakeholders and customers to ensure appropriate document management, use, standards application and control occur.
  • Provide support during audits of regulatory agencies.
  • Other duties as assigned

About you:

  • BS/BA with 5-7 years of document control experience supporting GMP documentation programs and systems in pharmaceutical or biopharmaceutical industries
  • Technical writing experience a plus
  • Firm understanding of FDA and global requirements related to cGMP documentation
  • Strong oral and written communication skills
  • Excellent interpersonal, teamwork, and organizational skills
  • Must be capable of multi-tasking and performing assignments that have loosely defined objectives with minimal supervision
  • Expert Proficiency with Microsoft products and document publishing software (e.g. Excel and Adobe Pro); must be able to learn additional applications as needed
  • Must be able to work in a fast-paced environment and function under pressure
  • Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

 

This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular.  bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE.  We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.

bluebird bio, 60 Binney Street, Cambridge, MA 02142 www.bluebirdbio.com

 

bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.

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