Quality Assurance Lead – Environmental Monitoring & Facility Validation

📋 Description

• Develop, maintain, and coordinate SOPs, work instructions, forms, training materials, and other
• Partner with site quality representatives and subject matter experts to standardize processes and
• Support investigations, deviations, CAPAs, change controls, and implementation of corrective
• Assist with accreditation, audit readiness, regulatory compliance, and data integrity requirements.
• Track quality initiatives, maintain records, and provide recommendations for process improvements.
• Support onboarding of new laboratory sites and other quality-related projects as assigned.

🎯 Requirements

• Bachelor's degree in a scientific or quality-related field.
• 3+ years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or
• Experience with quality systems, SOP development, investigations, CAPAs, and training documentation.
• Familiarity with eQMS, LIMS, environmental monitoring, and applicable regulatory requirements.
• Strong organizational, communication, problem-solving, and project management skills.
• Ability to manage multiple priorities, work independently, and travel as needed.

🎁 Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays