QC Specialist
Core
Establish and operate a state-of-the-art Environmental Monitoring (EM) laboratory at a new manufacturing facility to ensure compliance with global quality standards and GMP requirements.
Role type
Senior IC QC Specialist (Environmental Monitoring)
Builds
Environmental monitoring programs, qualification reports, and compliance documentation for vaccine and biological manufacturing.
Domain
Biopharmaceutical manufacturing / Environmental Monitoring
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Environmental Monitoring (EM) operations, GMP regulations (EU/US), Microbiology laboratory bench testing, IQ/OQ/PQ qualification, LIMS data review, CAPA management, SOP development, microbial isolate conservation
Preferred skills
Risk-Based Approach, Operational Excellence, cross-functional collaboration
Technologies
LIMS, air samplers, particle counters, isolators, BSCs
Responsibilities
Develop EM sampling plans for routine, BSC, isolator, and aseptic qualification activities; Lead qualification and requalification (IQ/OQ/PQ) of EM equipment; Lead investigations related to EM excursions, deviations, and contamination events; Act as SME and trainer for EM personnel; Perform quarterly EM trending and manage microbial isolate conservation program.
Seniority
Mid-to-Senior, hands-on IC