Quality Control Analysts - Microbiology (Multiple Openings)

Durham, NC, United States
Sep 15, 2018
Required Education
Bachelors Degree
Position Type
Full time
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 release and stability testing for multiple stages of our gene therapy and immune oncology products. This includes performing microbiological methods, environmental monitoring, data review and trending and implementation of GMP operational support systems ensuring a compliant Quality Control lab. The candidate will interface with Manufacturing, Facilities, Quality Assurance and other functions as required. A strong cGMP, operational and technical background in microbiological methods and environmental monitoring will be needed. This position will require hands on laboratory time. The level of the positions filled will be commensurate with experience.

About the Role:
  • Perform cGMP Microbial testing (Endotoxin, Bioburden, Environmental Monitoring, and others)
  • 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
  • Lead, author, perform, review, and/or approve equipment validations with minimal guidance
  • Implement, lead and/or 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 test method validation protocols 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 or other related field
  • 3+ years of experience in a cGMP/GxP environment is preferred
  • Hands on experience with environmental monitoring, facility qualification, bioburden, endotoxin, and other Microbiological methods
  • 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