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Capricor Therapeutics

Biotech developing cell- and exosome therapeutics

Quality Control Associate - Environmental Monitoring

Regulatory & Quality (Life Sciences)Updated on Nov 7
Full-timeSan Diego, CA, USA$65k - $85k /yr

About the Job

Requirements

  • A bachelor's degree in Life Sciences, Chemistry, Microbiology, or a related field is required.
  • Two to five years of experience in environmental monitoring or quality control within a regulated environment, such as pharmaceutical, biotechnology, medical device, or similar.
  • Knowledge of Good Manufacturing Practices (GMP), International Organization for Standardization (ISO) requirements, Food and Drug Administration (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.
  • Ability to work the swing shift schedule, with Sunday-through-Thursday or Tuesday-through-Saturday options; typical hours are 12:00 PM to 9:00 PM. Flexibility for occasional adjustments to shift times or days is required.
  • Ability to work in laboratory, cleanroom, and manufacturing environments; perform prolonged standing and extended computer use; and lift equipment or materials up to 20 pounds.

Responsibilities

  • Conduct routine environmental monitoring in controlled and classified areas in alignment with Good Manufacturing Practices (GMP), International Organization for Standardization (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 corrective and preventive actions (CAPAs).
  • Maintain calibration, readiness, and routine upkeep of environmental monitoring equipment.
  • Support audit and inspection readiness through compliant documentation and area oversight.
  • Collaborate with Quality Control (QC), Quality Assurance (QA), and Production to address findings, implement improvements, and maintain a state of control.
  • Consistently follow gowning and cleanroom entry procedures and perform duties in full cleanroom attire.
  • Participate in continual learning, safety programs, and ongoing process improvements.

Desired Qualifications

  • Experience with viable and non-viable particle monitoring, active air sampling, and cleanroom incubation workflows.
  • Familiarity with Laboratory Information Management Systems (LIMS) or other laboratory information systems.
  • Experience supporting audits, inspections, or environmental monitoring program review.
  • Experience troubleshooting trends or environmental anomalies.

About the Company

Capricor Therapeutics

Biotech developing cell- and exosome therapeutics

Capricor Therapeutics develops cell- and exosome-based therapies for serious diseases. Its products are derived from cells and the tiny particles cells release, aiming to repair or protect tissues in heart disease, Duchenne Muscular Dystrophy, and COVID-19 complications. The company advances these treatments through research and clinical trials to demonstrate safety and effectiveness before pursuing commercialization with hospitals and partners. Its goal is to improve patient outcomes by bringing validated cellular and exosome-based therapies to market and to advance medical science through collaboration.

Company size
201-500
Company stage
IPO
Headquarters
San Diego, CA
Founded
2005

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