HOW YOU’LL FLY

This is a hands-on role within Quality Control (QC) Operations, reporting to the Director of QC Operations. In this role, you will provide a significant contribution to the daily operations within Quality Control. You will partner with various internal laboratory operations as well as our Contract Testing Organizations (CTO) network. A normal day will include supporting all activities associated with testing at CTOs from sample submission to Certificate of Analysis (COA) approval. Additionally, you will provide valuable support in investigating any anomalous or out-of-specification results and/or driving QC document improvements through bluebird bio’s quality system.

You'll help to bring more patients their bluebird days by: 

• Compiling, reviewing, and archiving CTO data and test records in support of COA generation
• Inputting lot and test data into QC trackers
• Scheduling sample shipments
• Owning and/or supporting testing related deviations, laboratory investigations, CAPAs and out-of-specification (OOS) results
• Supporting document revisions related to method lifecycle and analytical method implementation
• Tracking & trending QC metrics

WHAT YOU’LL BRING

You’re the bird we’re looking for if you have: 

• BS in a scientific discipline and 3 years of related experience in QC GMP environment in a clinical and/or commercial environment
• Highly collaborative team player with experience being part of a team and working cross functionally
• Excellent organizational skills with an ability to navigate software and tools such as Veeva and Excel spreadsheets
• Experience with CTO/CMO interaction preferred

Contract Length: 12 months

Location: Remote (East coast based) or MA hybrid.