QC Specialist II - Aseptic Processing
Core
Ensuring product quality and patient safety through laboratory testing, scientific investigations, and monitoring of aseptic processes in a pharmaceutical manufacturing environment.
Role type
Quality Control Specialist (Aseptic Processing)
Builds
Pharmaceutical products meeting quality, compliance, and reliability standards
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
Analytical testing, Microbiological testing, Environmental monitoring, Stability testing, Deviation investigation, CAPA definition, Data integrity, GMP compliance, Aseptic processing knowledge, Equipment calibration
Preferred skills
Statistical process control, Validation activities, Supplier qualification, KPI analysis, Technical reporting
Technologies
Laboratory equipment, Stability testing systems, Monitoring tools
Responsibilities
Handle deviations and define CAPAs, Ensure compliance with cGxP including data integrity, Execute stability studies and protocols, Perform microbiological QC on materials and utilities, Maintain and calibrate equipment, Support supplier qualification, Monitor and analyze KPIs, Report technical complaints within 24 hours
Seniority
Mid-level, hands-on IC