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.
Lead Specialist, Quality Operations, Quality Assurance (Contract)
This role is for a 6-month contract position.
ABOUT THE FLOCK
The Quality Assurance flock is all about getting stuff done and working collaboratively. Whether it’s making sure we’re supporting and enabling our customers to create and maintain compliant and purposeful processes, documents, and records in a quality system that supports the global organization, working collaboratively across the nest, or driving innovation as a unit, we are driven by effective communication, critical thinking, and the ability to ask questions while supporting one another. Come work with an energetic and enthusiastic group of birds that loves rising to the challenge much as we do!
HOW YOU’LL FLY
We seek an experienced Quality professional to join our North Carolina manufacturing facility. The Quality Operations Lead Specialist will support the organization by ensuring conformance to established quality processes and standards while actively working to continuously improve them. In this position you will be responsible for resolution of quality issues encountered while manufacturing and testing, including deviations, change controls, and CAPAs.
As a Lead Specialist, Quality Operations bird reporting to Director, Quality Operations, you'll help to bring more patients their bluebird days by:
- Support bluebird bio Manufacturing Operations during batch production, ensuring unexpected events are handled compliantly.
- Manage data review, analysis, identification of trends, and complex problem solving.
- Review and approve documents including: Manufacturing batch records in support of product release; Standard Operating Procedures; Process Validation Protocols and Reports.
- Prepare and review documents associated with deviations, investigations, OOS results, and CAPA action plans.
- Support Supplier Quality, including supplier complaints and corrective actions.
- Ensure all documentation complies with cGMP regulations and industry guidelines.
- Manage problems of diverse scope using a high degree of judgment and risk-based decision making.
- Build on relationships with Manufacturing Operations ensuring quality issues are tracked and resolved in a timely manner.
- Track and trend quality system generation providing periodic updates to Management including: Review and approval of deviations, CAPA, and Change Control, and perform Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check as required.
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
- Other related tasks as needed
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- BA/BS and a minimum of 6-8 years in Quality Assurance/Quality Control in the pharmaceutical/biopharmaceutical industry
- Knowledge of working and master cell banks and industry guidance
- Knowledge of cell culture and upstream manufacturing
- Knowledge of chromatography and downstream manufacturing
- Knowledge of isolator technology and sterile filling practices
- Experience with disposition, investigations, change control, and process qualification and validation
- Strong knowledge of GxP regulations, quality systems, and guidance documents
- Ability to communicate above and below level in a way that fosters relationship building
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- 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.