Quality Assurance Assistant – Environmental Monitoring & Facility Validation
Core
Draft, maintain, and support quality systems and documentation for environmental monitoring and facility validation services across a US laboratory network.
Role type
Quality Assurance Assistant (Environmental Monitoring & Facility Validation)
Builds
Quality procedures, training materials, checklists, and documentation for EM/FV services
Domain
Life Sciences / Laboratory Services / Environmental Monitoring
Required skills
SOP development, quality documentation management, CAPA tracking, data integrity (21 CFR Part 11, ALCOA+), regulatory compliance (ISO/IEC 17025, GMP/GLP), project management
Preferred skills
Environmental monitoring experience, cleanroom certification knowledge, EU GMP Annex 1 familiarity, ISO 14644 series knowledge
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 leadership.
Seniority
Mid-level, experienced IC