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.
Analyst, Quality Control, Laboratory Operations
ABOUT THE FLOCK
The Quality Control Laboratory Operations flock is all about enthusiastic collaboration. Help contribute to the overall success of our novel gene therapy. The focus of this position will support the Quality Control Laboratory by assisting with the scheduling, tracking and performance of instrument/equipment maintenance, supporting validation/qualification programs, and maintaining the validated state of our equipment/instruments. The successful individual will support operational continuous improvements as well as multidisciplinary, multi-site, moderate to complex projects. Come work with this high-paced group of birds that love rising to the challenge and being apart of something so important.
HOW YOU’LL FLY
As a Quality Control Validation bird reporting to the Laboratory Operations manager you'll help to bring more patients their bluebird days by:
- Support the QC testing lab in scheduling, tracking and performance of instrument/equipment maintenance and calibrations with Facilities department.
- Support operational systems (equipment alarm monitoring, data integrity and control, cGMP documentation, LIMS, laboratory audits, and training).
- Support review of existing controls (equipment alarm monitoring, audit trails, etc.).
- Work cross functionally with site teams (Facilities, QAV, CSV, IT, etc.).
- Author SOPs, FORMs, and technical reports.
- Provide support in the development and execution of internal validation / qualification documentation.
- Author, review, and execute equipment and instrument validations with guidance.
- Act as Owner for Change Controls for support of instrument and equipment validation with guidance.
- Initiate deviations and support investigations, perform assessments, author protocols and reports, and investigation closures.
- Support CAPA and continuous improvement initiatives.
- Participate in providing necessary information for regulatory filings and inspections.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Bachelors’ in Engineering, Biochemistry, Biology, or related field required. Technical understanding of biopharmaceutical production.
- Bachelor’s degree with 3+ years GMP experience.
- Individual who can work with limited direction in a fast-paced, goal-oriented environment.
- General knowledge of cGMP guidelines.
- Familiar with Data Integrity requirements.
- Excellent written and verbal communication skills including the ability to communicate, influence and negotiate across the organization.
- Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
- Strong analytical ability.
- Experience supporting internal regulatory and partner inspections.
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise.
- Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.
- Familiar with flow cytometers, PCR instruments, plate readers/washers, HPLC, pH/osmometers, pH meters, osmometers, and/or temperature chambers.
- Be ready to embrace 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.