Quality Control Associate - Environmental Monitoring

Capricor Therapeutics • San Diego - SD1, CA

2d

About The Position

The Quality Control Associate for Environmental Monitoring plays a critical role in maintaining the environmental conditions required for GMP manufacturing. This position performs routine and specialized sampling, analyzes trends, documents results, and helps ensure controlled areas comply with regulatory and internal quality standards. The role includes hands-on monitoring of air, surfaces, personnel, water systems, and utilities, maintaining accurate real-time documentation, and supporting investigations into environmental excursions or anomalies. Working closely with QC, QA, and Production, the associate helps keep manufacturing and testing environments in a constant state of control to support production of high-quality therapeutic products.

The position requires significant time in GMP cleanrooms, including full gowning, and follows a swing shift schedule. Primary shift options are Sunday through Thursday or Tuesday through Saturday, typically from 12:00 PM to 9:00 PM. Hours or days may be adjusted based on business needs, and the assigned shift will be confirmed before the start date.

Requirements

• 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, such as pharmaceutical, biotech, or medical device.
• Knowledge of GMP, ISO, FDA expectations, and environmental monitoring standards.
• Experience performing environmental sampling and handling environmental monitoring 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.

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 environmental monitoring program review.
• Strong communication and cross-functional collaboration skills.
• Experience troubleshooting trends or environmental anomalies.

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.
• Promptly escalate atypical results 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.

Benefits

• Employer-sponsored medical coverage
• Employer-sponsored dental coverage
• Employer-sponsored vision coverage
• Company-paid basic life and AD&D insurance
• 401(k) plan with company match
• Paid time off
• Company holidays
• Paid parental leave
• Additional voluntary benefits and wellness programs may be available
• May be eligible for a discretionary annual performance bonus
• Depending on the level of the role, may be eligible for long-term equity incentive awards

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level