Senior Quality Specialist
Core
Ensure product quality, regulatory compliance, and operational excellence across manufacturing operations by managing batch releases, quality records, and defect analysis.
Role type
Senior Quality Specialist (GMP Manufacturing)
Builds
High-quality pharmaceutical/biotech products for customers
Domain
Life Sciences / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Batch record review, product release management, quality documentation, defect analysis, SAP proficiency, Manufacturing Execution Systems (MES) experience, quality data analysis, continuous improvement methodologies
Preferred skills
Cross-functional collaboration, audit support coordination, problem-solving in fast-paced environments
Technologies
SAP, Manufacturing Execution Systems (MES), Microsoft Office
Responsibilities
Perform batch record review and compliance verification for product release; Maintain and manage quality records, batch documentation, and retained samples; Evaluate product quality through physical and manufacturing defect inspections; Analyze defect trends and drive continuous improvement initiatives; Coordinate oversight for non-conforming materials; Support customer, health authority, and internal audits; Maintain SAP master data and quality management systems
Seniority
Senior, hands-on IC
