Quality Assurance At-the-Source Specialist, Cell Therapy

Typical Accountabilities

• Maintain a consistent Quality presence in manufacturing areas and provide real-time, practical guidance that supports safe, compliant, and reliable execution.

• Support manufacturing unit operations from a Quality Assurance perspective and assist to resolve manufacturing events and/or quality events in real-time

• Independently assess routine and moderately complex quality situations, integrate available facts and risk considerations, and determine appropriate action or escalation within established standards.

• Partner across functions to clarify requirements, align decisions, remove barriers, and sustain appropriate Quality independence.

• Recognize emerging risks, recurring issues, and performance gaps; communicate implications and recommend proportionate actions.

• Lead defined problem-solving and improvement activities, ensuring decisions are evidence-based, clearly documented, and carried through to effective resolution.

• Coach colleagues on quality thinking, disciplined execution, data integrity, contamination control, and right-first-time behaviors.

• Contribute quality judgment to operational meetings, shift handoffs, readiness discussions, and cross-functional decision forums.

• Manage multiple priorities independently, communicate changes in risk or urgency, and maintain reliable follow-through in a fast-paced patient-focused environment.

• Support inspection readiness and represent Quality confidently within the scope of training, experience, and delegated authority.

• Work a shift-based schedule of four days per week, Wednesday through Saturday, and support occasional off-hours or holidays as needed for manufacturing operations and patient commitments.
• The role may require additional responsibilities as necessary.