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 12-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 provide Quality Operations Support and Oversight for Quality Control Laboratory. The Quality “QA for QC” Team oversees resolution of quality systems encountered on in-process and lot release testing, and stability testing performed both in our internal GMP QC Testing Laboratory, and at our CTO’s, as well as supports the Stability, Critical Reagents teams with protocol and report generation.
In addition, there will be external vendor relationship and communication needed to support efficient and compliant processes and program management.
As a Lead Specialist, Quality Operations bird reporting to Senior Director, Quality Services, you'll help to bring more patients their bluebird days by:
- Management of data review, analysis, identification of trends, and complex problem solving.
- Review and approve documents including testing records, stability and qualification protocols and reports, QC lab investigations, retest plans, deviations, expiration extensions and supporting trend analyses, and change controls.
- May be called on to assist in manufacturing batch record review and review of internal documentation and forms in support of product lot release.
- Prepare, review and approve quality system documentation associated with deviations, investigations, OOS results, and CAPA action plans.
- Ensure all documentation complies with cGMP regulations and industry guidelines.
- Track and trend quality system generation internally and at CTOs.
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
- Engage in activities to continuously assess and improve Quality processes.
- Support the development, implementation, and revision of corporate quality systems.
- 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 8 years in Quality Assurance and/or Quality Control, including experience with external CxO quality oversight. Previous QC Lab experience and/or support highly desired
- Experience and/or knowledge of cellular therapy collection, processing and upstream manufacturing beneficial, but not required
- Experience and/or knowledge of QC biopharmaceutical testing, cell-based assays, stability program management are all plusses.
- Experience with writing, reviewing and approving deviation investigations, OOS lab investigations, change control, CAPA development and process improvements
- Ability to communicate above and below level in a way that fosters relationship building, including cross-functional teams, and external relationships with vendors
- Strong knowledge of GxP regulations, quality systems, and guidance documents (including ICH)
- Excellent organizational and project management skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities and multiple stakeholders
- Experience interacting with contract testing organizations, including identifying, communicating and resolving complex issues
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines
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.