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Form of workMonday - Friday, 8am - 5pm with possible call
NextGen Cell Therapy and Bone Marrow Transplant Lab
Salary: $68,266 - $111,426
Job Summary:
The Laboratory Quality Specialist provides facilitation for process improvement initiatives and oversees all quality processes within the Cell Processing Laboratory. Responsible for maintaining accreditation of all governing bodies.
Detailed Description:
Lead development and auditing of quality systems that ensure not only compliance but excellence and efficiency.
Monitor and update policies and procedures to be compliant with accrediting agencies. Review manuals annually.
Review new and revised standards and checklists from CAP, CLIA, DNV, and FACT etc.
Prepare, participate, and respond to required accreditation inspections and implement corrective actions.
Monitor and perform supplier qualification, supplier monitoring processes, environmental control, and monitoring systems.
Responsible for the preparation of equipment and process validation protocols, documentation of results, statistical analysis, generation of reports, and ensuring appropriate validation prior to implementation.
Prepare departmental reports for presentation on a regular basis. Communicate trends and opportunities for improvement to key process owners.
Perform process for documentation, investigation, and reporting of adverse reactions or events during cell therapy product collection or infusions. Review and report system or product deviations to appropriate internal and external parties.
Function as back-up for all Cellular Processing Laboratory processes.
Support the functions of the main MU Health Care laboratories as needed.
May complete unit/department specific duties and expectations as outlined in department.
A Bachelor's degree in Medical Technology or Clinical Quality Management, or a related field. Individuals who have qualified as a medical technologist by February 28, 1992 may substitute an associate's degree. Three (3) years of experience in apheresis, cellular processing, or cell manufacturing.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met with or without reasonable accommodation. The performance of these physical demands is an essential function of the job. The employee may be required ambulate, remain in a stationary position and position self to reach and/or move objects above the shoulders and below the knees. The employee may be required to move objects up to 10 lbs.
