Environmental Monitoring QC Associate - GMP Cleanrooms

Capricor Therapeutics, Inc.

San Diego (CA)

On-site

USD 70,000 - 95,000

Full time

10 days ago

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Benefits offered by this job

401(k) match
Medical/dental/vision coverage
Paid time off
Parental leave

Job summary

Capricor Therapeutics, Inc. seeks a Quality Control Associate for Environmental Monitoring to monitor air, surfaces, water, and equipment in GMP facilities. You will document results, identify trends, and support CAPAs, deviations, and audits in collaboration with QC, QA, and Production.

Cleanroom protocols and data integrity are essential as you support ongoing manufacturing testing. Required: Life Sciences degree and 2–5 years in EM or QC within regulated environments, GMP/ISO/FDA knowledge,

Qualifications

  • 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.

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 corrective or preventive actions.
  • Escalate atypical results promptly and support investigations, 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 and implement improvements.

Skills

EM experience
GMP/ISO/FDA knowledge
Documentation & data integrity
Cleanroom experience
Time management

Education

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

Tools

LIMS

Job description

Capricor Therapeutics, Inc. seeks a Quality Control Associate for Environmental Monitoring to monitor air, surfaces, water, and equipment in GMP facilities. You will document results, identify trends, and support CAPAs, deviations, and audits in collaboration with QC, QA, and Production.

Cleanroom protocols and data integrity are essential as you support ongoing manufacturing testing. Required: Life Sciences degree and 2–5 years in EM or QC within regulated environments, GMP/ISO/FDA knowledge,

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