Quality Assurance Assistant – Environmental Monitoring & Facility Validation
Core
Support the VP in building and maintaining quality systems for environmental monitoring and facility validation across a US laboratory network.
Role type
Quality Assurance Assistant (Environmental Monitoring & Facility Validation)
Builds
Quality systems, SOPs, training materials, and documentation for EM/FV services
Domain
Life Sciences / Laboratory Services / Environmental Monitoring
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SOP development, CAPA management, data integrity (21 CFR Part 11, ALCOA+), regulatory compliance (ISO/IEC 17025, GMP/GLP), project management, technical writing
Preferred skills
Cleanroom certification, EU GMP Annex 1, USP, ISO 14644 series
Technologies
eQMS, LIMS, viable air samplers, particle counters, compressed gas/dew point instrumentation
Responsibilities
Draft and maintain EM SOPs and work instructions; Assist with accreditation and audit readiness; Develop training content and competency assessments; Support investigations, deviations, and change controls; Track quality initiatives and process improvements; Escalate matters to VP; Integrate new lab sites into quality systems
Seniority
Mid-level, experienced IC