Website Integrated Resources, Inc
Integrated Resources, Inc
Company : Integrated Resources, Inc
Job Title: Environmental Monitoring Specialist
Schedule
- Monday Friday, 8:30 AM 5:00 PM
- Occasional weekend or vacation 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 facility s 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
- Bachelor s 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 settings