Uncubed
   

Analyst, Sample and Records Management, Quality Control

Bluebird Bio, Cambridge, Massachusetts, United States

integrated product platforms with broad therapeutic potential


On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business (“Oncology Newco”) as a new entity, with the completed transition expected by the end of 2021.

 

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

The Quality Control flock is all about enthusiastic and collaborative teamwork and contributing to the overall success of our novel gene therapy approach. The Records Management function is responsible for creating, collecting, issuing, reconciling, filing and performing the archiving of Quality Control controlled documents. Whether it’s supporting laboratory operations activities, managing quality records to ensure compliance in the Quality Control lab, or interfacing externally with CMOs, or cross-functionally with Quality Operations, Supply Chain, Quality Assurance, IT, Facilities, we are driven by our patients. Come work with an flocking awesome group of birds that loves rising to the challenge!

HOW YOU’LL FLY

As a Quality Control bird reporting to our Sample Management team, you'll help to bring more patients their bluebird days by:

  • Leading and coordinating sample shipments with cross-functional teams, receiving samples into Quality Control program, distribute samples to the appropriate testing lab, maintain sample inventory and perform sample destruction on a paper base system. Assist with stability and critical reagent sample pulls.
  • Drive, coordinate, schedule, and participate in equipment and instrument maintenance and calibration
  • Helping to support deviations and investigations, operational systems (equipment/instrument maintenance/calibration, equipment alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, and laboratory audit preparation), and CAPA/Continuous Improvement Initiatives
  • Participate in providing the necessary information for regulatory filings and inspections
  • Successfully authoring SOPs/Forms with document training and management guidance
  • Participate in cleaning the laboratory

WHAT YOU’LL BRING

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

  • Have a BS or AS with 2+ years in experience in a cGMP environment is preferred
  • Are experienced in following SOP instruction and record data contemporaneously using GDP (Good Documentation Practices)
  • Are familiar with(tools or programs that will be used frequently)
  • Have excellent interpersonal, interdependent partnering skills, collaboration competencies; within and across organization
  • Manage time effectively with an acute attention to detail
  • Promotes adherence to Quality policies and procedures.
  • Must be able recognize deviation from written procedure and report to management
  • A passion for addressing the critical unmet medical needs of patients

Applicant must be flexible to work the following shifts:

  • Eight-hour shifts (a.m., p.m., or overnight) on a fixed or rotating schedule
  • Four ten-hour shifts followed by three days off
  • Several 12-hour shifts followed by several days off

 

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.

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.