Quality Control Specialist

• MondayFriday, 8:30 AM 5:00 PM
• Occasional weekend or holiday work (rare)

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.

• 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

• Conduct environmental monitoring testing
• Review, analyze, and trend environmental data
• Provide regular reports on environmental status and emerging trends

• Ensure adherence to Good Manufacturing Practices (GMP)
• Investigate environmental excursions and contamination events
• Identify root causes and implement corrective actions

• Create and maintain technical documentation for the EM program
• Train technicians on:
  • Aseptic techniques
  • Gowning procedures and qualifications

• Work independently to identify risks and improve monitoring processes
• Develop and implement corrective and preventive actions (CAPA)

• Bachelors degree (required)
• Knowledge of Microsoft Office (Word, Excel, PowerPoint)
• Understanding of Good Manufacturing Practices (GMP)

• Minimum 3 years of experience in a GMP environment
• Experience in environmental monitoring within manufacturing or laboratory settings