Quality Assurance Validation, Sr. Specialist I/II - NC
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, analytical instrument qualification and associated laboratory computer systems validation. These activities will encompass technology transfer and commercial projects. The successful individual will own, lead or support multidisciplinary, multi-site, moderate to complex projects.
About the role:
About the role:
- Provide QA support, input and oversight for the internal QC testing laboratory and manufacturing site
- Provide QA support for validation activities including:
- Process Validation
- Analytical instrument qualification, use and maintenance
- Computer systems validation
- Equipment and Facilities commissioning, qualification, use and maintenance
- Cleaning validation (SIP and CIP)
- Provide guidance, review and approval of internal validation documents including validation plans, requirement documents (URS, FS, CS), protocols, data analysis, and final reports.
- Review and approval of changes to validated systems in support change controls including assessment of impact
- Ability to drive the implementation of new policies and procedures to support bluebird bio quality systems for internal testing and manufacturing.
- 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.
- Works closely with all site functional teams (Manufacturing, Facilities, QC, etc) responsible for protocol development and execution to provide QAV support.
- 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.
- Support the development of long-range goals and objectives
- Exercise considerable latitude in determining objectives and approaches to critical assignments.
- Wide range of expertise working in an internal GMP manufacturing or laboratory environment
- Expertise in support of analytical laboratory instrumentation and equipment qualification
- 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.
- Knowledgeable of Data Integrity requirements.
- 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 5-10%
- Experience within a multi-product facility is a plus
- Experience using risk based approaches (FMEA, PHA, etc).
- Project management experience.
- 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