Quality Assurance Lead – Environmental Monitoring & Facility Validation
Core
Build and maintain quality systems and documentation for environmental monitoring and facility validation services across a US laboratory network.
Role type
Senior Quality Assurance Lead (Environmental Monitoring & Facility Validation)
Builds
Quality procedures, training materials, checklists, and documentation supporting laboratory accreditation and regulatory compliance.
Domain
Life Sciences / Environmental Monitoring / Laboratory Services
Required skills
SOP development, quality investigations, CAPA management, training documentation, data integrity (21 CFR Part 11, ALCOA+), GMP/GLP principles, project management
Preferred skills
Cleanroom certification, EU GMP Annex 1, USP, ISO 14644 series, eQMS/LIMS familiarity
Technologies
eQMS, LIMS, viable air samplers, particle counters, compressed gas/dew point instrumentation
Responsibilities
Draft and maintain EM SOPs and work instructions; Support accreditation and audit readiness; Develop training content and competency assessments; Assist with investigations, deviations, and change controls; Track quality initiatives and process improvements; Integrate new laboratory sites into quality systems.
Seniority
Senior, hands-on IC with network-wide scope