Quality Systems Specialist II
Core
Support complex Quality Systems activities including deviations, investigations, CAPAs, and change controls to ensure regulatory compliance and record progression.
Role type
Mid-level Quality Systems Specialist (Regulatory/Manufacturing)
Builds
Inspection-ready quality records and compliant QMS processes for biopharma clients
Domain
Biopharmaceutical manufacturing and regulated industries
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> dashboards & analysis (Quality KPIs) and client delivery (audit support)
Required skills
GMP regulations knowledge, deviation/investigation management, CAPA development, change control, root-cause analysis, risk assessment, document control, audit/inspection readiness, data reconciliation
Preferred skills
Sterile/biologic manufacturing experience, electronic quality management systems proficiency, client/regulatory agency interaction
Technologies
Electronic quality management systems, quality-data reporting tools
Responsibilities
Independently support deviations, investigations, CAPAs, and change controls; Review quality records for completeness and compliance; Coordinate with Manufacturing, QC, and Engineering; Support root-cause analysis and risk assessments; Track records against timelines and escalate risks; Collect and report Quality KPIs; Support audit and inspection readiness; Provide training and guidance to junior staff
Seniority
Mid-level, operates independently with periodic guidance for complex issues
