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About Capricor Therapeutics
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 a Quality Engineering Associate III to join our R&D group. This position will work in collaboration with the Quality Engineering team to support operations and continuous improvement efforts for the San Diego Capricor GMP Facility. This role will ensure compliance with Capricor procedures and all applicable regulatory guidelines.
Responsibilities:
Lead equipment and facilities CQV activities based on Capricor internal procedures
Work collaboratively with other site functions such as manufacturing, Facilities, Safety, and the quality organization.
Collaborate with the Quality Engineering team to identify process improvements and recommend changes.
Assist in the review of Calibrations, Preventive Maintenance, and service reports for Equipment’s and Facilities.
Provide Quality support of the change control technical
assessment/evaluation
process. Prepare reports and documents for review related to
Equipment/Facilities
and maintenance activities. Ensure alignment of
equipment/facilities
with Capricor’s procedures. Support regulatory inspections and audits. Conduct risk assessments using appropriate tools such as Failure Mode Effects Analysis (FMEA), Risk Matrix, Decision Tree, etc. Support vendor qualification and compliance audits.
technical/investigation
reports as appropriate Track, review and report metric information for use in continuous improvement of areas of responsibility. Support continuous improvement initiatives and projects within the site’s quality organization Perform other duties as required Requirements: Bachelor’s Degree and 2+ years’ experience in pharmaceutical or FDA environment Minimum of 3 years of Quality Engineering or validation experience in a GMP environment (Drug Substance or Drug Product) Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10) Experience leading greenfield or brownfield facility buildouts Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, Quality Assurance, GMPs, Health Authority Regulations and Validation
practices/principles Knowledge of audit principles, GMPs and quality assurance Proficient in MS Word, Excel, Power Point and other applications Strong written and verbal communication skills Ability to communicate and work independently with
scientific/technical
personnel 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: $75,000 - $95,000 annually This role offers a competitive salary based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development. Location Policy: This position is based at our headquarters in San Diego, California, with flexibility for occasional remote work as needed. 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. If you are excited about joining a team that’s transforming the biotech industry, we’d love to hear from you!
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assessment/evaluation
process. Prepare reports and documents for review related to
Equipment/Facilities
and maintenance activities. Ensure alignment of
equipment/facilities
with Capricor’s procedures. Support regulatory inspections and audits. Conduct risk assessments using appropriate tools such as Failure Mode Effects Analysis (FMEA), Risk Matrix, Decision Tree, etc. Support vendor qualification and compliance audits.
technical/investigation
reports as appropriate Track, review and report metric information for use in continuous improvement of areas of responsibility. Support continuous improvement initiatives and projects within the site’s quality organization Perform other duties as required Requirements: Bachelor’s Degree and 2+ years’ experience in pharmaceutical or FDA environment Minimum of 3 years of Quality Engineering or validation experience in a GMP environment (Drug Substance or Drug Product) Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10) Experience leading greenfield or brownfield facility buildouts Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, Quality Assurance, GMPs, Health Authority Regulations and Validation
practices/principles Knowledge of audit principles, GMPs and quality assurance Proficient in MS Word, Excel, Power Point and other applications Strong written and verbal communication skills Ability to communicate and work independently with
scientific/technical
personnel 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: $75,000 - $95,000 annually This role offers a competitive salary based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development. Location Policy: This position is based at our headquarters in San Diego, California, with flexibility for occasional remote work as needed. 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. If you are excited about joining a team that’s transforming the biotech industry, we’d love to hear from you!
#J-18808-Ljbffr