Quality Control Specialist 503B
Core
Ensures product quality, compliance, and manufacturing continuity across 503A and 503B operations through inspection, sampling, testing coordination, and documentation.
Role type
Quality Control Specialist (Pharmaceutical Manufacturing)
Builds
Compliant pharmaceutical products for patient distribution
Domain
Healthcare / Pharmaceutical Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, inspection execution, sampling, deviation management, CAPA, change control, audit readiness, electronic quality management systems, data integrity, regulatory alignment (FDA/USP), analytical problem-solving
Preferred skills
AI-enabled quality systems, digital workflow platforms, laboratory communication, process enhancement, cross-functional collaboration
Technologies
Electronic quality management systems, AI-enabled analytics tools, automated workflows, digital documentation platforms
Responsibilities
Perform material inspections, sampling, and quality verification; coordinate sample management and testing activities; draft and assist in Nonconformance investigations and CAPA activities; maintain accurate audit-ready records; support audits and inspections; identify opportunities for process enhancement.
Seniority
Mid-level, hands-on IC
