Quality Compliance Specialist (Quality Risk Management)
Core
Facilitate quality risk assessments and reviews to support internal drug product manufacturing operations and the Quality System.
Role type
Quality Compliance Specialist (Quality Risk Management)
Builds
Quality risk management programs and documentation for manufacturing processes
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality risk management principles, FMEA, RBIA, REM, HACCP methodologies, change control, deviation management, contamination control strategy, aseptic processing risk assessment, audit preparation, data-driven decision making
Preferred skills
Veeva system proficiency, coaching and training experience
Technologies
Microsoft Word, Excel, PowerPoint, Veeva
Responsibilities
Facilitate data driven risk assessments and risk reviews, partner with Risk Assessment Owners to define scope and criteria, guide teams through risk identification and mitigation, prepare and revise QRM documents, contribute to contamination control strategy and aseptic processing risk assessments, support regulatory and internal audits, track metrics for continuous improvement
Seniority
Specialist (2+ years) or Sr Specialist (5+ years)
