Associate Specialist, Quality Systems
Core
Provide quality assurance support for manufacturing processes of pharmaceutical products, medical devices, combination products, and biologics, ensuring compliance from raw material inspection through final shipment.
Role type
Associate Specialist, Quality Systems
Builds
Quality systems and compliance documentation for drug, biologics, device, and combination products
Domain
Pharmaceutical and medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system review, specification review, change request management, quality metric data collection, training program participation, regulatory compliance knowledge
Preferred skills
Knowledge of pharmaceutical/biological/medical device products, process/equipment/facilities familiarity
Technologies
Computerized systems
Responsibilities
Assist with integration and support of quality regulations, perform quality review of quality system and computerized system changes, complete and route change requests for process documents, support project teams in quality documentation planning and approval, collect and compile key quality metric data, participate in training and education programs
Seniority
Entry-level (0-2 years experience)