ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
Sample Control and Records Management Analyst II– Quality Control Laboratory
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek a QC Analyst to support commercial level GMP testing laboratories for release and stability for multiple stages of our gene therapy products. This position will focus on QC Sample Control and QC Records Management, including but not limited to: sample receipt, storage, and maintenance, shipping no behalf of QC support functions, purchasing and maintaining supplies, equipment maintenance, controlled copy generation, record reconciliation and archival, and coordination supporting GMP systems to ensure a compliant Quality Control lab. The candidate will work cross-functionally with Manufacturing Sciences/CMO, Method Monitoring and Critical Reagents, Quality Operations, Supply Chain, Quality Assurance, IT, Facilities, and other support function teams as required. cGMP will be utilized in the role.
HOW YOU’LL FLY
As a Quality Control bird, you'll help to bring more patients their bluebird days by:
- As a QC Sample and Records Management Analyst II bird reporting to QC Manager, you'll help to bring more patients their bluebird days by:
- Sample Management - prepare for, receive, appropriately store, and ship samples.
- Records Management – assume responsibility as controlled copy generator, distribute, reconcile, and archive controlled copies.
- Coordinate scheduling of, prepare for, and pack-in of shipments of QC support functions
- Maintenance of sample inventory logs and disbursement of samples to testing lab
- Author SOPs/Forms with document training and management
- Support deviations and investigations
- Support operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, and laboratory audit preparation)
- Support CAPA/Continuous Improvement Initiatives
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- BS or AS with 2+ years in experience in a cGMP environment is preferred
- Must follow SOP instruction and record data contemporaneously using GDP (Good Documentation Practices)
- Must be able recognize deviation from written procedure and report to management
- 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 demonstrates ability work with limited direction in a fast-paced, goal-oriented environment
- Provide exemplary customer service
- Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.