Overview
Oncology Imaging Quality Control Specialist I Jobs in Wisconsin at MERIT CRO Inc
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a Los Angeles, CA based cutting-edge biotech company focused on the discovery and development of novel cell and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders. Capricor’s lead product candidate, allogeneic Cardiosphere-Derived Cells (CDCs), known as CAP-1002, is being investigated as a treatment for Duchenne muscular dystrophy and COVID-19. In addition, the Company is conducting research and development on its exosomes platform technology for a variety of indications. In response to a global pandemic, our team is currently applying its technologies to deploy a novel vaccination approach against COVID-19. Capricor offers exciting opportunities and invites qualified professionals to join our expanding team. Capricor provides competitive compensation and benefits packages.
Position: Quality Assurance Associate 1 – Quality Operations (Los Angeles)
Capricor is 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, deviation investigation, label issuance, and word processing, tracking, issuing, distributing, and archiving companywide GLP / GCP / GMP controlled documentation, training, and facility support systems.
Knowledge of standard processes involved in document control and experience in an FDA regulated environment is required. The position will report to the Quality Assurance Supervisor.
Responsibilities:
Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping.
Review controlled documents per established procedures to ensure process compliance.
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 / 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.
Inventory database management including accurate and timely updating of lot numbers and quantities.
Review inspection records for release of incoming raw materials for GMP use in accordance with approved specifications.
Other required duties as may be assigned.
Requirements:
Bachelor’s Degree. 1+ years-experience (at least some in a cGMP environment)
Experience in Aseptic Processing a plus
Precise attention to detail
Excellent record keeping skills skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems
Good oral communication skills, strong written communication skills
Familiar with Quality Systems and records management in a cGMP environment.
Strong problem-solving skills
Ability to coordinate and perform multiple activities
Results oriented with dedication to compliance and customer service
Strong initiative and follow-through
Comfortable working in a fast paced and dynamic environment.
Compensation (USD): $60,000 – $70,000
This role offers a competitive salary based on experience and qualifications. Additional benefits include health insurance, retirement plans, and opportunities for professional development. (Note: Salary range is estimated based on typical roles at this level; adjust as needed.)
Location Policy:
This position is based in Los Angeles, California, with some flexibility for remote work depending on organizational policies.
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.
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! At Capricor, you’ll be part of a forward-thinking team committed to improving lives through groundbreaking therapies. If you’re passionate about clinical quality assurance and supporting innovative biotech operations, we invite you to apply and help shape our future.
Title: Oncology Imaging Quality Control Specialist I
Company: MERIT CRO Inc
Location: Wisconsin
