Specialist I, QA Validation
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role:
ElevateBio is looking for a Specialist I to join their growing QA Validation team at BaseCamp Pittsburgh. In this role, the Specialist I will provide QA oversight for commissioning, qualification, and validation (CQV) activities at the site related to facilities, utilities, equipment, analytical instruments, methods, and computer systems. A successful candidate has a thorough understanding of regulatory requirements and industry best practices for CQV, is collaborative and comfortable working with cross-functional departments, and is eager to apply innovative solutions for continuous improvement efforts.
Here’s What You’ll Do:
- Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories.
- Provide QA oversight for initial environmental monitoring performance qualifications for cleanrooms.
- Perform review of quality records including deviations, CAPAs, and change controls.
- Perform review of CMMS records related to asset management including asset release and work orders.
- Author and perform review of SOPs in Veeva.
- Work cross-functionally to identify and implement CAPAs from related deviations or based on opportunities for improvement.
- Liaise with project teams to develop project schedules, escalate issues, track milestones, and ensure adherence to program timelines.
- Collaborate with other ElevateBio sites to harmonize the global validation program
Requirements:
- Bachelor’s degree in a technical discipline with 3+ years validation and/or quality assurance experience.
- Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation.
- Knowledge of paperless validation systems.
- Prior experience working in cell and gene therapy manufacturing preferred.
- Experience with Kneat strongly preferred.
- Applies collaborative approach to problem solving and is experienced with risk-based decision making.
- Team player who works well in large multi-disciplinary project groups by listening effectively and inviting open discussion.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.