Quality Control Specialist
Core
Manage the Environmental Monitoring (EM) Program for manufacturing areas, cleanrooms, and critical utilities, ensuring compliance with cGMP and regulatory standards.
Role type
Quality Control Specialist (Environmental Monitoring)
Builds
Monitored and controlled manufacturing environments and utilities
Domain
Pharmaceutical manufacturing / Biologics
Required skills
Environmental monitoring operations, Gas monitoring operations, Equipment qualification (IQ/OQ/PQ), Microbiological methods, Regulatory knowledge (cGMP), Data integrity, LIMS usage, SOP/WI management, Microbial isolate conservation
Preferred skills
Microbiological identification, Clean utilities testing
Technologies
LIMS, Air samplers, Particle counters
Responsibilities
Develop EM sampling plans for routine, BSC, isolator, and qualification activities; Coordinate and manage EM sampling schedules; Review EM and gas sampling results for accuracy and compliance; Lead equipment qualification and requalification activities; Lead investigations related to EM excursions and contamination events; Manage microbial isolate conservation program; Support health authority inspections and audits as SME.
Seniority
Mid-level, hands-on IC