Job Abstract

SUMMARY

The primary purpose of the Coordinator, CBB Quality position is to manage the equipment and facility in compliance with the Cord Blood Bank (CBB) Quality Assurance program, and all applicable regulatory and accreditation agencies. Assist with the selection and qualification of new equipment and critical supplies/reagents. Manage equipment inventory using existing applications and assist with development of new management and tracking systems and processes. Assist with writing, editing and training of staff for equipment SOPs and validations. Schedule periodic performance maintenance, calibration and repair of new and existing equipment and review all associated records for completion and accuracy. Assist with the review of quality control records for accuracy and completion and assist with record retention program as defined by Quality Assurance Program.

The ideal candidate will have quality control experience in a clinical, cell therapy, or cGMP lab or cord blood or general blood banking experience. Must have experience performing routine quality control activities with laboratory instrumentation.

JOB SPECIFIC COMPETENCIES
Equipment and Facility Management and Documentation

a. Responsible for ensuring compliance for all CBB equipment including equipment qualification, calibration, and maintenance. Responsible for ensuring all calibration and maintenance activities are completed in a timely manner to maintain regulatory compliance, equipment reliability and support the timely delivery of safe products for patients. Ensure all documentation is organized/filed and available for inspection or review within 24 hours. b. Responsible for coordinating on-site calibration and maintenances services. Assist with procurement of service contracts with equipment critical supply vendors. c. Perform technical reviews of all IQ, OQ and PQ documentation for existing equipment. d. Ensure proper documentation of equipment related deviations, initiate investigations and assist quality assurance in evaluating possible causes, identify root causes of equipment issues and assist in timely implementation of correction actions. e. Serve as the technical resource for all equipment during business and non-business hours. f. Manage equipment and facility monitoring system: including documentation and investigation of alarm situations. Perform or schedule IQ, OQ, PQ of monitoring systems as applicable and with appropriate vendor or institutional department and maintain accurate and complete documentation records. Generate and maintain records for monthly reports of all probes. Monitor and report monthly performance indicators for facility monitoring, and critical temperature controlling equipment. g. Responsible for writing, reviewing and revising technical standard operating procedures and policies related to equipment, reagents and supplies, ensuring they are updated to include regulatory and agency changes. Maintain associated equipment manuals. h. Ensure the management of critical supplies, equipment and vendors in the QA validated electronic inventory application. Create or review records for receipt and quarantine of equipment. Manage data for existing equipment as well as retirement of equipment. Partner with CBB management and procurement to ensure preventative maintenance contracts on all equipment are renewed in a timely manner. i. Schedule and liaise with vendors performing maintenance and remedial work, monitoring process and performance of the work and ensuring documentation is turned in from the service provider. j. Maintain sufficient and current knowledge of technical procedures, policies and applicability of respective regulations and standards including but not limited to FDA’s
Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices regulations as well as standards set by other accreditation agencies including but not limited to FACT, FACT/Netcord and CAP. k. Participate in audit program, both internal and external/vendor inspections and provide input to audit reports.

Data Management and Review

a. Review daily, weekly, monthly equipment and quality control worksheets and logs for accuracy and completion. Ensure all documentation is organized/filed and available for inspection or review within 24 hours. b. Perform weekly review of completed product qualification sheets. Qualify and release Hetastarch batches for use. Assist with media qualification as needed. Review and release all media for use. c. Assist with the review of Environmental Monitoring (EM) data, report data monthly to CBB management, and participate in investigation of failures. d. Assist with review of sterility test results in CBiS and complete all associated WebSTAR tasks. Ensure positive samples are sent to MD Anderson Micro Lab for identification and rejected products and associated samples are discarded. Report sterility results and trending at monthly CBB Management meetings and participate in root cause investigations. e. Ensure Sysmex Insight is submitted and review reports for trends. f. Assist with summarizing data and results for EM and Sterility as directed. g. Provide status updates for Equipment Management to CBB management team biweekly and contribute to the periodic Quality Management report.

Quality Control of Equipment, Supplies and Reagents

a. Contribute to risk assessments and assist with preparation, control and completion of equipment qualification studies following defined plans, in a timely manner. Train, assist, and mentor employees assigned to performing qualification studies. Compile and provide data to CBB Management or other designated staff. b. Develop and perform technical reviews of all IQ, OQ and PQ documentation for new equipment. Train staff on the use and maintenance of new equipment, including QC checks and staff competency. Responsible for coordinating the qualification of equipment SOPs. Assist, guide and mentor employees assigned to performing such studies. c. Assist with the design, execution, and summarization of designated validations, developing the corresponding SOPs and worksheets. d. Coordinate and perform, as needed, equipment qualifications, ensuring all documentation is complete and records are organized and filed. f. Create product qualification sheets for all new supplies/reagents. As directed, investigate alternative supply options and complete risk assessments for QA review.