Quality Control Associate - Environmental Monitoring

Role Summary

The Quality Control Associate, Environmental Monitoring ensures the environmental conditions required for GMP manufacturing are maintained. You will perform routine and specialized sampling of air, surfaces, water, and equipment, analyze trends, document results, and support investigations into excursions or anomalies. Working with QC, QA, and Production, you will help keep manufacturing and testing environments in a controlled state to support the production of high-quality therapeutic products.

Responsibilities

• Conduct routine environmental monitoring in controlled and classified areas in alignment with GMP, ISO, and regulatory requirements
• Perform sampling of air, surfaces, water, and equipment using approved methods
• Document sampling activities and results accurately in accordance with GMP and data integrity standards
• Analyze environmental monitoring data to identify trends, excursions, and required corrective or preventive actions
• Escalate atypical results promptly and support the investigation, documentation, and closure of deviations and CAPAs
• Maintain calibration, readiness, and routine upkeep of environmental monitoring equipment
• Support audit and inspection readiness through compliant documentation and area oversight
• Collaborate with QC, QA, and Production to address findings, implement improvements, and maintain a state of control
• Follow gowning and cleanroom entry procedures consistently and perform duties in full cleanroom attire
• Participate in continual learning, safety programs, and ongoing process improvements

Qualifications

• Required:
  • Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or a related field
  • 2–5 years of experience in environmental monitoring or quality control within a regulated environment (pharmaceutical, biotech, medical device, or similar)
  • Knowledge of GMP, ISO, FDA expectations, and environmental monitoring standards
  • Experience performing environmental sampling and handling EM equipment
  • Strong documentation, data integrity, and analytical skills
  • Ability to work effectively in controlled environments, including cleanrooms
  • Strong organizational and time-management skills for handling multiple priorities
• Preferred:
  • Experience with viable and non-viable particle monitoring, active air sampling, and cleanroom incubation workflows
  • Familiarity with LIMS or other laboratory information systems
  • Experience supporting audits, inspections, or EM program review
  • Strong communication and cross-functional collaboration skills
  • Experience with troubleshooting trends or environmental anomalies

Skills

• Data analysis and trend identification
• Documentation and record-keeping
• Clear written and verbal communication
• Cross-functional collaboration
• Problem-solving and troubleshooting

Education

• Bachelor’s degree in Life Sciences, Chemistry, Microbiology, or a related field

Additional Requirements

• Significant time spent in GMP cleanrooms, including full gowning
• Prolonged standing during sampling activities and extended computer use for documentation and trending
• May require lifting of equipment or materials up to 20 pounds
• Ability to work within laboratory, cleanroom, and manufacturing environments as part of routine monitoring
• Shift/Schedule: Swing shift to support operational needs; Primary shift options: Sunday through Thursday or Tuesday through Saturday; Typical hours: 12:00 PM to 9:00 PM (may vary); Flexibility for schedule changes may be necessary