Lead Validation Analyst, QC Laboratory Operations

Company: bluebird bio
Location: Cambridge
Posted on: February 15, 2021

Job Description:

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.

Lead Validation Analyst, QC Laboratory Operations

About The Flock

The Quality Control flock is all about enthusiastic collaboration. Whether it's making sure the QC Laboratory is supported with validation and qualification programs, maintaining the validated state of our equipment and instruments, or ensuring compliance and data integrity we are driven by the results we are able to drive in support of our greater goal. 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:

• Develop, author, and execute internal validation/qualification documentation for analytical instruments/equipment, including URS, IOQ, PQ, RTM, and summary reports.
• Schedule and coordinate validation activities with system owners, vendors, and key stakeholders
• Lead the change-control aspects of validation, ensuring validation impact assessment, procedural impact, regulatory impact, and prescribed testing are adequate and well justified.
• Interface with Validation, Quality Assurance, IT, CSV, System Owners, and key stakeholders to facilitate timely protocol execution and remediate issues during protocol execution.
• Proven capacity to lead cross functional teams.
• Assist with the development and execution of data integrity initiatives in the QC Lab.
  • Represent the QC Lab Ops in project teams, audits, and inspections as required
  • Support equipment and instruments maintenance, calibration, periodic assessment, equipment alarm monitoring, data integrity and control, cGMP documentation, LIMS, laboratory audits and training.
  • Contribute to continuous improvement projects including instrument/equipment validation and data integrity.
  • Mentor and assist with developing junior/new staff
  • Perform training sessions on QC Lab Op owned procedures to QC staff and external groups, as needed.
    
    What You'll Bring
    
    You're the bird we're looking for if you:
    
    • Have a bachelor's degree with 7+ years GMP experience or Master's degree with 3+ years GMP experience. GMP experience is required.
    • Are experienced in validating analytical instrumentation and equipment (e.g. flow cytometers, qPCR, UPLC, automated cell counters, automated DNA extractors, plate readers, plate washers, biosafety Cabinets, refrigerators, LN2, and freezers).
    • Are familiar with cGMP guidelines, ICH Q7, Q8, Q9, Q10, GAMP5 and other international regulatory requirements, or guidance, relevant for equipment/instrument/computer system validation.
    • Have excellent leadership skills to lead cross functional teams to ensure project success. Superb 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.
    • A can-do attitude that includes an initiative and ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
    • Are driven to improve processes and work in a collaborative environment to increase efficiency and compliance without sacrificing quality for our patients.
      All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, 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.

Keywords: bluebird bio, Cambridge , Lead Validation Analyst, QC Laboratory Operations, Professions , Cambridge, Massachusetts