Specialist I, QA Validation

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.