Quality Operations Senior Specialist
Bluebird Bio, Durham, North Carolina, United States
integrated product platforms with broad therapeutic potential
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
Join bluebird bio’s enthusiastic and collaborative Quality Operations team to contribute to the overall success of our novel gene therapy approach. We seek an experienced Quality professional to join our North Carolina manufacturing facility. The Quality Operations Senior Specialist I will support the organization by ensuring conformance to established quality processes and standards while actively working to continuously improve them.
HOW YOU’LL FLY
• Support bluebird bio Manufacturing Operations during batch production, ensuring unexpected events are handled compliantly and in a timely manner.
• Support disposition for bluebird bio starting materials and manufactured products.
• Review and approve documents including: Manufacturing batch records in support of product release; Standard Operating Procedures, Process Validation Protocols and Reports;
• Perform Shop Floor QA activities: line clearances, area release, GMP walkthroughs.
• Ensure all documentation complies with cGMP regulations and industry guidelines.
• Provide support to regulatory inspections.
• Manage problems of diverse scope using a high degree of judgement and risk-based decision making.
• Support batch execution metrics, providing input to Management – alignment to target Turnaround Times and Disposition dates, number of comments and deviations per batch.
• Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
• Management of data review, analysis, identification of trends, and complex problem solving.
• Engage in activities to continuously assess and improve Shop Floor Quality, Lot Review and Disposition processes.
WHAT YOU’LL BRING
• BA/ BS and a minimum of 3-5 years in Quality Assurance / Quality Control
• Knowledge of cell culture and upstream manufacturing
• Knowledge of chromatography and downstream manufacturing
• Knowledge of isolator technology and sterile filling practices
• Knowledge of working and master cell banks and industry guidance
• Experience with Shop Floor Quality programs
• Experience with disposition, investigations, change control, and process qualification and validation
• Ability to communicate above and below level in a way that fosters relationship building
• Strong knowledge of GxP regulations, quality systems, and guidance documents
• Ability to travel approximately 5-15%
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.
Innovative, fast-paced, challenging.. we're everything you want in a workplace.
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