Senior Specialist, QC Support, Cell Therapy

Senior Specialist position managing the lifecycle of QC laboratory equipment at a cell therapy facility, including validation, qualification, and maintenance activities. Reports to QC management and requires a Bachelor's degree with 4+ years of regulated laboratory experience.

Responsibilities

• Manage lifecycle activities of QC laboratory equipment including commissioning and decommissioning
• Create equipment user requirements, validation protocols, and related technical documents
• Schedule and facilitate qualification, calibration, maintenance and repairs performed internally or by vendors
• Maintain equipment records and electronic databases in compliance with GMP requirements
• Conduct troubleshooting, CAPA investigations, change management and continuous improvement efforts

Requirements

• Bachelor's degree in science or equivalent required; advanced degree preferred
• 4+ years relevant laboratory experience in regulated environment
• Strong understanding of cGMP and global regulatory requirements
• Demonstrated equipment qualification and validation experience
• Advanced knowledge of computerized systems (SAP, Valgenesis, Maximo preferred)
• Technical writing skills and data integrity knowledge
• High problem-solving ability and cross-functional communication skills

Compensation: $91,180 - $110,488 base