Senior Specialist, Quality Assurance Validation

Location
Cambridge, MA, United States
Posted
Oct 30, 2018
Ref
1413809
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Sr. Specialist, Quality Assurance Validation

Join bluebird bio's enthusiastic and collaborative Quality Assurance Validation (QAV) team to contribute to the overall success of our novel gene therapy. This position will support the organization through the establishment of bluebird bio validation/qualification programs across disciplines and ensure alignment with industry standards in accordance with the relevant product's lifecycle. In this position, you will be responsible for guidance and quality review/approval of internal protocols and reports related to process manufacturing equipment qualification, cleaning validation, computer systems validation and analytical instrument qualification. These activities will encompass IND-enabling, pre-clinical, clinical and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, moderate to complex projects.

About the role:
  • Provide QA support, attend team meetings, provide input and oversight for the internal QC testing laboratory and internal/external manufacturing for bluebird bio products.
  • Provide QA support for validation activities including:
    • Analytical instrument qualification, use and maintenance
    • Enterprise and laboratory computer systems validation
    • Facility, utility, systems and equipment (FUSE) commissioning, qualification, use and maintenance
    • investigation and approval of Validation Excursions/Deviations
  • Provide guidance, review and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), qualification protocols, data analysis, and final reports.
  • Review and approval of changes to validated systems, including operational computer systems, in support of change controls (including assessment of impact).
  • Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
  • Ability to multitask and prioritize independently in a high paced environment.
  • Thorough knowledge and understanding of FDA and foreign requirements and expectations.
  • Represent the Quality Assurance Validation group in project teams, audits and inspections as required.
  • Support the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
  • Exercise considerable latitude in determining objectives and approaches to critical assignments.

About You:
  • Wide range of expertise working in an internal GMP manufacturing or laboratory environment
  • Expertise in support of manufacturing equipment qualification, analytical instrumentation qualification and computer systems validation
  • Thorough knowledge and experience with change control process
  • Bachelors' and/or Masters' degree in Engineering, Biochemistry or related field required. Technical understanding of biopharmaceutical production.
  • A minimum of five (5) years of experience in the industry, ideally all clinical phases through commercial drug product.
  • Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for process, cleaning and equipment validation.
  • Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
  • Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
  • Ability to travel approximately 10%
  • Experience within a multi-product facility is a plus
  • Experience using risk based approaches (FMEA, PHA, etc).
  • Strong analytical ability.
  • Experience supporting internal regulatory and partner inspections.
  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
  • Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself