Quality Assurance Assistant - Environmental Monitoring & Facility Validation

Quality Assurance Assistant supporting environmental monitoring and facility validation across a US laboratory network. The role develops and maintains quality systems documentation, procedures, and training materials while ensuring compliance with GMP/GLP standards and laboratory accreditation requirements.

Responsibilities

• Draft, revise, and maintain SOPs, work instructions, forms, and templates for environmental monitoring services
• Maintain quality documentation for laboratory accreditation and scope compliance
• Collaborate with subject matter experts to capture technical requirements in procedures and training materials
• Build and maintain training content, competency assessments, and associated records
• Support investigations, deviations, CAPAs, and change controls with documentation and network context

Requirements

• Bachelor's degree in scientific or quality-related field
• 3+ years GMP-regulated pharmaceutical, biotech, medical device, or laboratory experience
• Quality systems expertise including SOP development, investigations, CAPAs, training
• Knowledge of eQMS, LIMS, environmental monitoring, and regulatory requirements
• Strong organizational, communication, and project management skills
• Ability to manage multiple priorities independently and travel as needed