Quality Control Associate, Environmental Monitoring

Capricor Therapeutics is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our proprietary StealthX platform to engineer innovative treatments. Our team is committed to harnessing cutting-edge science and advanced technologies to meet the unmet needs of patients living with DMD and other challenging medical conditions. Join us on our journey as we push the boundaries of medical science and pave the way for a healthier future.

About The Role

We are seeking highly motivated candidates who are capable of independent work in a collaborative environment for a Quality Control Associate I/II. This position will need to perform routine environmental monitoring, coordinate shipping of samples for outsourced testing, perform data analysis, and assemble and complete QC data documentation. Products may include cells, exosomes, and other regenerative therapeutics.

Responsibilities

• Carry out Environmental Monitoring of manufacturing facility and relevant samples generated
• Interface with outsourced laboratories to coordinate sample receipt, testing, and on time reporting of results
• Perform data analysis, organize records, reports and databases in a timely manner
• Write technical reports or documentation such as deviations and investigation of OOS results
• Train other employees to perform relevant techniques and procedures as needed
• Write or revise quality control Standard Operating Procedures
• Coordinate with third party vendors to maintain calibration of equipment
• Work closely with the Manufacturing and Quality Assurance department staff to resolve issues regarding the facility and products manufactured
• Work under minimal supervision to meet project goals; and
• Other duties as assigned

Requirements

• Ability to gown and work in a classified area. Aseptic processing a plus.
• Bachelor’s degree in a relevant Biological Science discipline
• 2+ years of experience working in a GMP Quality Control laboratory or a combination of experience in a GMP/GLP setting is preferred
• Demonstrated history of successful, independent laboratory microbiology work
• Excellent communication, time-management skills and the ability to work as part of a team
• Ability to work with Outlook, MS Office, and other electronic systems

Work Environment / Physical Demands

• Must be able to sit and stand for extended periods.
• Must be able to lift / carry reports and materials up to 40 pounds, move about the office.

Compensation (USD)

• Salary Range: $70,000 to $80,000 annually.
• This role offers competitive compensation based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development.

Role Specific Location Policy

This role is based at our headquarters, with flexibility for remote work as needed. Occasional travel may be required for audits and regulatory inspections.

Come work with us!

Capricor Therapeutics is headquartered in San Diego, California. We offer competitive compensation and benefits, generous vacation and parental leave, flexible working hours, and a collaborative work environment.