Quality Assurance Associate II
San Diego, CA
Quality – Quality Assurance /
Full-time (exempt) /
On-site
Capricor Therapeutics, a publicly traded (NASDAQ: CAPR) biotechnology leader, is driven by a mission to develop groundbreaking biologics—focusing on cell and exosome-based therapies—to make a meaningful impact on patients’ lives, particularly for severe conditions like Duchenne muscular dystrophy with our lead therapy, deramiocel (CAP-1002). Our innovative work extends to our StealthX™ exosome platform, harnessing cutting-edge science to address unmet medical needs through precision-engineered solutions. At the heart of everything we do is a deep commitment to patient-centered innovation, fueled by strong academic partnerships and a passion for advancing healthcare.
Position Overview: Quality Assurance Associate II
We are seeking a self-motivated team player with attention to detail, who enjoys organizing, making processes better, and making a difference in patient lives. The successful candidate will serve an essential role in supporting clinical product launch and production. This includes batch record review, review of raw materials, deviation investigation, label issuance, and word processing, tracking, issuing, distributing, and archiving company-wide GLP/GCP/GMP controlled documentation, training, and facility support systems. This position will be based at our headquarters in San Diego, CA.
Responsibilities:
- Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping.
- Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits. Write associated reports.
- Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system.
- Coordinate, track, and archive controlled records (i.e., batch/test records, logbooks, validation documents, labels, reports, forms, etc.) for change controls, deviations, CAPAs, audits, training, equipment calibration, and preventative maintenance.
- Write and/or review policies, standards, procedures, and work instructions to document Quality documentation processes and practices.
- Support supplier and material management, including ordering, incoming receipt, record keeping, etc.
- Perform review and release of incoming materials.
- Inventory database management, including accurate and timely updating of lot numbers and quantities.
- Collaborate on the development, improvement, and implementation of material, facility, and quality management systems.
- Other required duties as may be assigned.
Requirements:
- Bachelor’s Degree and 2+ years of experience in a cGMP environment.
- Knowledge of standard processes involved in document control and experience in an FDA-regulated environment.
- Experience in Aseptic Processing a plus.
- Precise attention to detail.
- Excellent record-keeping skills.
- Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems.
- 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.
- Comfortable working in a fast-paced and dynamic environment.
- Ability to gown and work in a classified area as required.
Work Environment and 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, communicate efficiently and effectively on the telephone or in person, and complete required paperwork.
$75,000 - $80,000 a year
Compensation (USD):
Salary Range: $75,000 - $80,000 annually
Comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development.
Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
