About the job
ElevateBio is a pioneering cell and gene therapy company that leverages cutting-edge technology to transform the future of medicine. Our innovative integrated technologies model offers comprehensive biotechnological capabilities, enabling genetic medicine processes and programs to reach their utmost potential.
Position Overview:
We are seeking a Quality Assurance Validation Specialist I to become a vital member of our expanding QA Validation team at BaseCamp Pittsburgh. In this role, you will be responsible for providing quality assurance oversight for commissioning, qualification, and validation (CQV) activities across various site functions, including facilities, utilities, equipment, analytical instruments, methods, and computer systems. The ideal candidate will possess a deep understanding of regulatory requirements and industry best practices for CQV, demonstrate strong collaborative skills across cross-functional teams, and show eagerness to implement innovative solutions for ongoing improvement initiatives.
Your Responsibilities:
- Oversee QA-related CQV activities within the cGMP manufacturing facility and quality control laboratories.
- Ensure QA oversight for initial environmental monitoring performance qualifications in cleanrooms.
- Review quality records, including deviations, CAPAs, and change controls.
- Evaluate CMMS records pertinent to asset management, including asset release and work orders.
- Draft and review Standard Operating Procedures (SOPs) within the Veeva system.
- Work collaboratively across teams to identify and implement CAPAs based on deviations and opportunities for enhancement.
- Engage with project teams to develop schedules, escalate issues, monitor milestones, and ensure compliance with program timelines.
- Collaborate with other ElevateBio locations to standardize the global validation program.

