Quality Associate
Core
Ensuring the safety and quality of manufactured medicine components pre- and post-production, focusing on release for supply activities.
Role type
Quality Associate (Pharmaceutical Manufacturing)
Builds
Manufactured medicines and components for global pharmacy and retail distribution
Domain
Pharmaceutical manufacturing / Regulatory Compliance (TGA/GMP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Assurance in manufacturing)
Required skills
Batch document review and release, Documentation control, Change control, Internal auditing, Root cause analysis (CAPA), Sampling and inspection of materials, GMP compliance interpretation, Data entry and trending, Supplier reassessment, Temperature and environmental monitoring
Preferred skills
Experience with ILAB/MRP/ERP systems, Continuous Improvement mindset, Problem-solving under pressure
Technologies
ILAB, MRP, ERP, Microsoft Office Suite
Responsibilities
Review batch documents for release, Conduct RO water sampling and conductivity testing, Organize environmental monitoring and maintain results, Monitor temperature loggers and pressure differentials, Perform deviation and CAPA investigations, Update Standard Operating Procedures, Maintain retention stores and master artwork, Assist in GMP training programs
Seniority
Mid-level, hands-on IC
