QC Analyst (Contract)
Bluebird Bio, Durham, North Carolina, United States
integrated product platforms with broad therapeutic potential
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 Analyst 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, water collection, and compressed gas monitoring, and implementation of GMP operational support systems to ensure a compliant Quality Control lab. The candidate will interface with Manufacturing, Facilities, Quality Assurance and other functions as required. An awareness of cGMP and an operational and technical background in microbiological and environmental monitoring methods will be needed. This position will require hands on laboratory time.
"• Perform cGMP Microbial testing (Environmental Monitoring, water collection, compressed gas testing, and others)
• Follow procedures and provide direction on deviations from the norms
• Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization.
• Implement and support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audit, and method training)
• Participate in providing the necessary information for regulatory filings and inspections
"• Minimum BS in Microbiology or other related field
• 1-2 years of experience in a cGMP/GxP environment is preferred
• Hands on experience with environmental monitoring, facility qualification, utility monitoring and other Microbiological methods
• Demonstrate a strong initiative
• 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
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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