Job Title: Environmental Monitoring Specialist Schedule MondayFriday, 8:30 AM 5:00 PM Occasional weekend or holiday work (rare) Position Summary This role is responsible for overseeing the Environmental Monitoring (EM) Program within an Advanced Cellular Therapeutics Facility. The individual will design, implement, and maintain a sustainable monitoring program to ensure compliance with quality and regulatory standards. The position requires collaboration with internal stakeholders and external vendors, along with independent decision-making to identify risks and improve processes. Key Responsibilities Program Development & Implementation Establish and implement the facilitys environmental monitoring program Collaborate with third-party vendors to define best practices Develop processes and schedules for ongoing monitoring activities Data Analysis & Reporting Conduct environmental monitoring testing Review, analyze, and trend environmental data Provide regular reports on environmental status and emerging trends Quality & Compliance Ensure adherence to Good Manufacturing Practices (GMP) Investigate environmental excursions and contamination events Identify root causes and implement corrective actions Documentation & Training Create and maintain technical documentation for the EM program Train technicians on: Aseptic techniques Gowning procedures and qualifications Continuous Improvement Work independently to identify risks and improve monitoring processes Develop and implement corrective and preventive actions (CAPA) Required Qualifications Bachelors degree (required) Knowledge of Microsoft Office (Word, Excel, PowerPoint) Understanding of Good Manufacturing Practices (GMP) Preferred Qualifications Minimum 3 years of experience in a GMP environment Experience in environmental monitoring within manufacturing or laboratory settingsI
Integrated Resources, Inc