Overview
QA/QC Coordinator Jobs in Saint Louis, MO at BASF Corporation
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’re looking for a Clinical Assurance Specialist who is detail-oriented, self-motivated, and a strong team player. The ideal candidate will have excellent organizational skills, a passion for process improvement, and a commitment to supporting work that makes a difference in patients’ lives. This role will be critical in supporting clinical product launches and production. Key responsibilities include batch record review, deviation investigations, label issuance and tracking, as well as managing companywide GLP/GCP/GMP-controlled documentation, training systems, and facility support. This position is onsite in Vista, CA.
Knowledge of standard processes involved in document control and experience in an FDA regulated environment is required
Responsibilities:
Support clinical product manufacturing by conducting batch record review/disposition, label printing, product packaging, and shipping.
Working knowledge of 21 CFR 210 and 211, ICH, ISO9001, EU Guidelines and other relevant FDA regulations is a must.
Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls. 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.
Collaborate on the development, improvement, and implementation training program, and other quality management systems, as assigned.
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 raw material program.
Inventory database management, including accurate and timely updating of lot numbers and quantities.
Perform review and release of incoming materials.
Support regulatory/submission activities, as required.
Ability to participate and prepare relevant materials for Management Review and Material Review Board meetings.
Perform other required duties as may be assigned.
Requirements:
Bachelor’s Degree and 5-7 years of experience in a cGMP environment
Experience in commercial cell therapy company is highly desired
Experience in Aseptic Processing is a plus
Attention to detail and excellent record-keeping skills
Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems
Good oral and strong written communication skills
Familiarity with Quality Systems and records management in a cGMP environment
Strong problem-solving skills and the ability to coordinate and perform multiple activities
Results-oriented with dedication to compliance and customer service
Strong initiative, independence and follow-through
Comfortable working in a fast-paced, cross functional team and dynamic environment
Comfortable dealing with rapidly changing priorities
Ability to gown and work in a classified area as required.
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, communicate efficiently and effectively on the telephone or in person, and complete required paperwork
Compensation (USD):
Salary Range: $100,000 to $110,000 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 Vista, CA location, with flexibility for 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. Join a passionate team committed to transforming the lives of patients and pushing the boundaries of medical science.
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Title: QA/QC Coordinator
Company: BASF Corporation
Location: Saint Louis, MO
