QC Specialist (Data Review & Investigations)
Job Description
The QC Specialist (Data Review & Investigations) is responsible for supporting Quality Control laboratory operations through comprehensive data review, laboratory investigations, deviation management, and GMP documentation activities in a Cell & Gene Therapy environment. This role ensures laboratory testing, data integrity, and documentation comply with current GMP regulations, internal procedures, and regulatory expectations.
The individual will work cross-functionally with QC, QA, Manufacturing, MSAT, and Validation teams to support clinical and commercial manufacturing activities.
The QC Specialist (Data Review & Investigations) is responsible for supporting Quality Control laboratory operations through comprehensive data review, laboratory investigations, deviation management, and GMP documentation activities in a Cell & Gene Therapy environment. This role ensures laboratory testing, data integrity, and documentation comply with current GMP regulations, internal procedures, and regulatory expectations.
The individual will work cross-functionally with QC, QA, Manufacturing, MSAT, and Validation teams to support clinical and commercial manufacturing activities.