Senior QC Compliance Specialist
Core
Senior QC Compliance Specialist ensuring adherence to regulatory standards and continuous improvement of quality systems for GMP manufacturing of biological products in an analytical laboratory.
Role type
Senior IC QC Compliance Specialist
Builds
GMP-compliant biological products (AAV, viral vectors, vaccines)
Domain
Biopharmaceuticals / Gene Therapies / Quality Control
Required skills
GMP compliance, CAPA management, deviation investigations, change control, quality metrics trending, audit readiness, SOP development, ICH guidelines, USP, EU GMP
Preferred skills
ddPCR, qPCR, ELISA, HPLC, CE-SDS, SDS-PAGE, LIMS, EDMS, ERP, Lean Operational Excellence
Responsibilities
Initiate and close QC CAPAs, investigations, and deviations; track and trend quality metrics; collaborate on CAPA effectiveness evaluations; maintain QC tracking mechanisms; monitor QC systems for compliance; execute audit readiness programs; participate in internal audits; support facility qualifications and startups.
Seniority
Senior, hands-on IC