Quality Control Analysts - Raw Materials (Multiple Openings)

Location
Durham, NC, United States
Posted
Oct 14, 2018
Ref
1224211
Required Education
Bachelors Degree
Position Type
Full time
Quality Control Analysts - Raw Materials (Multiple Openings)

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek multiple Quality Control Analysts to support establishing new commercial-level in-house GMP testing laboratories performing raw materials sampling and release testing for multiple stages of our gene therapy and immune oncology products. This includes performing analytical methods, data review and trending, implementation of GMP operational support systems ensuring a compliant raw materials testing program. A strong cGMP, operational and technical background in raw materials testing and USP, EP, and JP monographs will be needed for this position. This position will require hands on laboratory time. The level of the positions filled will be commensurate with experience.

About the Role:
  • Perform cGMP raw material inspection, sampling, and testing
  • Provide oversight for contract testing labs
  • Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization
  • Author, review, and/or approve SOPs/policies and technical reports with general guidance
  • Lead laboratory deviations and investigations (IA, OOS, AR), performing assessment, authoring protocols/reports and investigation closure with minimal guidance as required
  • Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
  • Execute phase-appropriate raw material qualifications as needed
  • Participate in providing the necessary information for regulatory filings and inspections.
  • Lead and support CAPA/Continuous Improvement Initiatives


About You:
  • Minimum BS in Microbiology, Chemistry, Biochemistry, or other related field
  • 2+ years of experience in a cGMP/GxP environment is preferred
  • Familiar with USP, EP, and JP monographs
  • Hands on experience with raw material testing and sampling
  • Demonstrate a strong initiative and scientific leadership
  • Direct experience in authoring and review/approval of SOPs
  • Superb organizational, analytical, and communications skills and "do-what-it-takes" attitude
  • A passion for addressing the critical unmet medical needs of patients
  • Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
  • Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself