Capricor Therapeutics, Inc.
Quality Assurance Associate I
Capricor Therapeutics, Inc., San Diego, California, United States, 92189
Overview
Capricor Therapeutics, a publicly traded biotechnology company (NASDAQ: CAPR), is focused on cell and exosome-based therapies to advance patient outcomes, including Duchenne muscular dystrophy with CAP-1002 and the StealthX exosome platform.
Position We are seeking a self-motivated team player to support clinical product launch and production, including batch record review, review of raw materials, deviation investigations, labeling, and GLP/GCP/GMP controlled documentation, training, and facility support systems. This role is located at Capricor’s headquarters in San Diego, CA.
Responsibilities
Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping
Coordinate deviation investigations, CAPA, change controls, company-wide training, and internal audits; write associated reports
Process controlled documentation within GxP documentation systems (word processing, tracking, issuing, distributing, archiving)
Coordinate/track/archive controlled records for change controls, deviations, CAPAs, audits, training, equipment calibration and preventive maintenance
Write and/or review policies, standards, procedures and work instructions to document quality documentation processes
Support supplier and material management, including ordering, receiving, and record keeping
Perform review and release of incoming materials
Manage inventory database with accurate lot numbers and quantities
Collaborate on development/improvement/implementation of material, facility, and quality management systems
Other duties as assigned
Requirements
Bachelor’s Degree and 2+ years in a cGMP environment
Knowledge of document control processes in an FDA-regulated environment
Experience in aseptic processing is a plus
Precise attention to detail; excellent record-keeping
Strong computer skills (MS Word, Excel, Visio, Access; Adobe suite; and databases)
Familiar with Quality Systems and records management in a cGMP environment
Strong communication and problem-solving skills
Results-oriented with dedication to compliance and customer service
Strong initiative and follow-through; able to work in a fast-paced environment
Ability to gown and work in a classified area as required
Work Environment
Must be able to sit and stand for extended periods
Capable of lifting/carrying up to 40 pounds
Occasional travel as required
Why Capricor? Capricor Therapeutics is a leading company in cell and exosome therapy, committed to patient-centered innovation and advancing healthcare through collaborative teamwork and scientific excellence. Join us to help transform lives and shape the future of medical science.
Benefits Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development.
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Position We are seeking a self-motivated team player to support clinical product launch and production, including batch record review, review of raw materials, deviation investigations, labeling, and GLP/GCP/GMP controlled documentation, training, and facility support systems. This role is located at Capricor’s headquarters in San Diego, CA.
Responsibilities
Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping
Coordinate deviation investigations, CAPA, change controls, company-wide training, and internal audits; write associated reports
Process controlled documentation within GxP documentation systems (word processing, tracking, issuing, distributing, archiving)
Coordinate/track/archive controlled records for change controls, deviations, CAPAs, audits, training, equipment calibration and preventive maintenance
Write and/or review policies, standards, procedures and work instructions to document quality documentation processes
Support supplier and material management, including ordering, receiving, and record keeping
Perform review and release of incoming materials
Manage inventory database with accurate lot numbers and quantities
Collaborate on development/improvement/implementation of material, facility, and quality management systems
Other duties as assigned
Requirements
Bachelor’s Degree and 2+ years in a cGMP environment
Knowledge of document control processes in an FDA-regulated environment
Experience in aseptic processing is a plus
Precise attention to detail; excellent record-keeping
Strong computer skills (MS Word, Excel, Visio, Access; Adobe suite; and databases)
Familiar with Quality Systems and records management in a cGMP environment
Strong communication and problem-solving skills
Results-oriented with dedication to compliance and customer service
Strong initiative and follow-through; able to work in a fast-paced environment
Ability to gown and work in a classified area as required
Work Environment
Must be able to sit and stand for extended periods
Capable of lifting/carrying up to 40 pounds
Occasional travel as required
Why Capricor? Capricor Therapeutics is a leading company in cell and exosome therapy, committed to patient-centered innovation and advancing healthcare through collaborative teamwork and scientific excellence. Join us to help transform lives and shape the future of medical science.
Benefits Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development.
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