QA for QC Specialist (15-month contract)
Core
QA for QC Specialist reviewing and dispositioning data from biologics clinical manufacturing QC labs to ensure quality and compliance.
Role type
QA for QC Specialist
Builds
Data integrity and compliance for clinical-stage biologics drug substance manufacturing
Domain
Biotechnology / Biologics Clinical Manufacturing
Required skills
cGMP knowledge, analytical sciences, data integrity, regulatory standards (Health Canada, FDA, EU, ICH), deviation/CAPA/change control management, QC instrumentation operations
Preferred skills
BSc/MSc in relevant scientific discipline, 3-5+ years industry experience, fast-paced environment adaptability, cross-functional collaboration
Technologies
QC equipment, electronic data systems, stability programs, environmental monitoring systems
Responsibilities
Review and disposition QC data (incoming materials, environmental monitoring, in-process bulk, stability, cell banking); Approve protocols and reports for equipment qualification, validation, and method transfers; Document and escalate QC data issues and OOT/OOS results; Participate in quality events (deviations, CAPAs, change controls); Compile QC data for regulatory submissions; Maintain facility inspection readiness
Seniority
Mid-level, hands-on IC
