Environmental Monitoring Quality Systems Specialist (GMP/QA)
Core
Develop, implement, and maintain quality systems for Environmental Monitoring and Facility Validation services across a U.S. laboratory network.
Role type
Quality Systems Specialist (GMP/QA)
Builds
Standard Operating Procedures (SOPs), quality documentation, training programs, and compliance records for EM and FV operations.
Domain
Pharmaceutical/Biotechnology Quality Assurance (GMP, GLP, ISO/IEC 17025)
Required skills
GMP quality systems, SOP development, technical writing, document control, eQMS/LIMS administration, investigation support, CAPA management, audit support, regulatory compliance (21 CFR Part 11, ALCOA+)
Preferred skills
Environmental Monitoring program support, cleanroom certification, microbiological testing, facility validation, ISO/IEC 17025 knowledge, EU GMP Annex 1, USP/ISO 14644 standards, environmental monitoring instrumentation
Responsibilities
Draft and maintain SOPs and quality documents; support eQMS and LIMS administration; develop training materials and competency assessments; support investigations, deviations, CAPAs, and change controls; participate in internal and regulatory audits; maintain quality metrics and action tracking; integrate new laboratory locations into network systems.
Seniority
Mid-level, hands-on IC
