Quality Control Associate - Environmental Monitoring

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

The Quality Control Associate for Environmental Monitoring (EM) plays a critical role in maintaining the environmental conditions required for GMP manufacturing. This position is responsible for performing routine and specialized sampling, analyzing trends, documenting results, and ensuring controlled areas maintain compliance with regulatory and internal quality standards. As part of the QC EM team, you will perform hands-on monitoring of air, surfaces, and personnel, as well as water system and utility testing to ensure facility integrity. You will be responsible for maintaining accurate, real-time documentation and supporting investigations into any environmental excursions or anomalies. Working closely with QC, QA, and Production, this role ensures that manufacturing and testing environments remain in a constant state of control 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.

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.