Vanessa Romin Email & Phone Number

Los Angeles, Ca, Us

Westwood, California, United States

• Provides guidance to maintain a quality and compliance program within the Bone Marrow Stem Cell Lab, Hemapheresis Unit, and Hematologic Malignancies/Stem Cell Transplantation Adult and Pediatric Clinical Program.• Performs audits of operational functions.• Review and evaluate reports of occurrences and adverse events.• Operate an internal audit program to monitor quality systems and operational functions to provide basis for performance and quality improvement.• Audit processes to assess compliance with approved SOPs as well as guidelines and standards of accrediting and regulatory agencies.• Provide for continual readiness for inspections for new and ongoing cellular therapy products.• Prepare operational workflows to meet contractual and product requirements.• Improve quality of services by providing system for detecting, reporting, evaluating, and preventing test failures, system failures, and errors.• Create patient presentation files for review during weekly patient selection meeting.• Define, collect, and analyze quality metrics and prepare reports for department management.

Irvine, California, United States

• Team member for leading quality improvement initiatives.• Conduct good documentation practices training for laboratory personnel. • Subject Matter Expert (SME) for the Document Control System.• Manage Quality Event Reporting (QER) and conduct root cause analysis. Ensure corrective actions and process improvements are effective and in accordance with CAP, CLIA, and NYSDOH standards.• Leader in equipment record management. Creates equipment record in QMS and documents maintenance, IQOQ, PQ, cleaning and other pertinent records for traceability.• Oversee internal and external proficiency testing conducted; communicates with CAP regarding updates made to test menu and PT enrollment. • Submit communicable disease reporting to state/municipal Department of Health. Responsible for communicating with states regarding updates to Electronic Disease Reporting (ELR) regulations. • Conduct internal audits to assess if standards are being met in accordance with CAP, CLIA, and NYSDOH standards.• Extract and present data for quality system metrics during quarterly audits. Utilizes PowerBi for data presentation during metrics meetings. • Collaborate with department managers to implement and uphold our Training and Competency Program.

Irvine, California, United States

• Under direct supervision of licensed testing personnel: Coordinate the daily activities of unlicensed laboratory staff in pre-analytical specimen preparation. • Oversee that all aspects of processing and handling specimens are carried out in an accurate, efficient, and timely manner. • Collect and review laboratory assistant’s competency assessment data for accuracy.• Creates workflow protocols and trains laboratory personnel on implementation. • Participates in instrument validation and verification procedures.• Assist quality assurance department with organizing instrument calibration records, administration and evaluation of employee competency assessments, and ensure all laboratory personnel fulfill training. • Enforce laboratory quality control policies and documents quality control activities.

Irvine, California, United States

• Aid clinical laboratory scientists by preparing extraction reagents using automated instruments and providing necessary plates and labels for processing.• Track and request laboratory supplies.• Perform specimen patient preparation, labeling, and handling. • Quickly comprehend directions and provide effective actions.• Maintain the laboratory’s organization and cleanliness.• Troubleshoot and resolve instrument issues. • Follow all procedures and protocols pertaining to accessioning and patient sample processing, pre-analytical, analytical, and general laboratory systems. • Assist with clerical duties assigned by Laboratory Management.

Chino Hills, California

• Analyze building materials by Polarize Light Microscopy and air by Phase Contrast Microscopy for asbestos fibers, along with other non-hazardous materials. • Perform data entry of results using the laboratory's information management program.• Complete general laboratory maintenance such as organizing paperwork, cleaning, and taking part in proficiency testing.