QC Compliance Specialist, 6-month contract

bluebird bio

Quality Control

August 7, 2014

QC Compliance Specialist, 6-month contract

Growing Gene Therapy Company

 

bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio’s product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.

 

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach.    We seek a Quality Control Compliance Specialist to assist and support the organization with compliance to established quality control procedures. You will support project activities, change control, validation, training, deviations, investigations, and other quality systems relating to internal and external testing.

 

Primary responsibilities:

  • Perform routine review of release and stability test data for GMP compliance, accuracy and in comparison to specification criteria.
  • Assure documentation is in compliance with cGMP regulations and other industry guidelines
  • Perform data trending and analysis.
  • Write and review QC SOPs, protocols and reports.
  • Work closely CTOs as applicable for successful resolution of deviations, investigations, CAPAs, Change Controls, etc.
  • Assist with writing and review of CMC sections of regulatory submissions.
  • Assist in the day-to-day Quality Assurance operations
  • Support efforts to continuously improve bluebird bio’s quality system management which will lead to improved compliance and greater efficiency

 

Requirements: 

  • Bachelor’s degree in a scientific discipline, a minimum of 5-7 years of related experience in Quality Control.
  • Experience authoring and reviewing SOP’s, protocols, and reports
  • Must have excellent attention to detail and ability to recognize inaccurate laboratory documentation.
  • Superb organizational and communication skills—both written and oral  and “do-what-it-takes” attitude

 

 

To be considered for this exciting career opportunity, please forward your resume with a cover letter to work@bluebirdbio.com.

bluebird bio, 150 Second Street, Cambridge, MA 02141 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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