Quality Control Analyst I - EM 503B
Core
Ensures product integrity, labeling accuracy, and regulatory compliance across 503A and 503B pharmaceutical operations using AI-enabled tools.
Role type
Quality Control Analyst I (Pharmaceutical Manufacturing)
Builds
Inspection execution, deviation identification, and release readiness for manufacturing, packaging, and distribution workflows.
Domain
Pharmaceutical manufacturing (503A/503B outsourcing facilities)
Deliverable
production ML models | product features | dashboards & analysis
Required skills
GMP knowledge, 503A/503B regulatory compliance, visual inspection, batch record validation, sampling control, deviation detection, audit preparation, continuous improvement, data analysis, SOP adherence, AI tool utilization
Preferred skills
None stated
Technologies
AI-enabled detection tools, digital tracking systems, AI-supported document analysis tools, AI-driven anomaly detection and reporting systems
Responsibilities
Perform detailed visual inspections of products and labels using AI-assisted tools; Validate batch records for completeness and GMP alignment; Execute sampling procedures with digital tracking; Monitor compliance deviations and trends using AI tools; Document and escalate product or labeling discrepancies; Prepare inspection data and documentation for internal and external audits; Identify inspection inefficiencies and recommend improvements using AI insights; Analyze inspection data trends to drive proactive quality improvements
Seniority
Junior to Mid-level, hands-on IC
