Quality Control Associate - Environmental Monitoring

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.

Required Qualifications

• 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 Qualifications (Nice‑to‑Haves)

• 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.

Work Environment & Physical Demands

• 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

• This position follows a swing shift schedule to support operational needs.


Schedule Details:
• Primary shift options:Sunday through Thursday | Tuesday through Saturday
• Typical hours: 12:00 PM to 9:00 PM (may vary based on business needs)
• Flexibility is required, and occasional adjustments to shift times or days may be necessary.
• We will confirm your assigned shift prior to your start date.