Quality Operations, Lead Specialist

Durham, NC, United States
Oct 05, 2018
Required Education
Bachelors Degree
Position Type
Full time
Join our growing Quality group

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 Lead Specialist, Quality Operations 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 overseeing batch and release testing review, resolution of quality issues encountered while manufacturing and testing, and generation of disposition documentation. Additionally, you'll work closely with the Quality Operations Management team to build the Quality Operations department as bluebird grows; creating an energized, efficient, and effective team.

About the position:
  • Support bluebird bio Manufacturing Operations during batch production, ensuring unexpected events are handled compliantly.
  • Manage disposition for bluebird bio starting materials and products.
  • 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.
  • 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.
  • Track and trend batch execution providing periodic updates to Management including: alignment to target Turnaround Times, disposition cycle times, and number of comments and deviations per batch.
  • Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
  • Engage in activities to continuously assess and improve Lot Review and Disposition processes.
  • Support the development, implementation, and revision of corporate quality systems.

About you:
  • BA/BS and a minimum of eight (8) years in Quality Assurance in the pharmaceutical/biopharmaceutical industry
  • Knowledge of working and master cell banks and industry guidance
  • Knowledge of cell culture and upstream manufacturing
  • Experience with disposition, investigations, change control, and process qualification and validation
  • Strong knowledge of GxP regulations, quality systems, and guidance documents
  • Demonstrated leadership within teams producing results
  • 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
  • Must have excellent attention to detail and time management skills, and the ability to manage multiple priorities with aggressive timelines
  • Must have excellent project management and organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Lean Six Sigma Green Belt - preferable but not required
  • Ability to travel approximately 5-15%
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself