Quality Assurance Lead – Environmental Monitoring & Facility Validation

📋 Description

• Draft, revise, and maintain environmental monitoring SOPs, work instructions, forms, and templates
• Assist with maintenance of quality documentation associated with laboratory accreditation and scope
• Work with designated subject matter experts for each service line, including cleanroom
• Develop and maintain a working understanding of the environmental monitoring equipment in use
• Build and maintain environmental monitoring training content, competency assessments, and
• Support data integrity requirements for EM field data capture, review, and reporting, including 21

🎯 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