Lab Quality Specialist (FT) Job at MU Health Care
Monday - Friday Days.
Department: Labs
Salary: $68,266 - $111,426
Job Summary:
The Laboratory Quality Specialist provides facilitation for process improvement initiatives and oversees all quality processes within the Cellular Processing Laboratory for the Blood and Marrow Transplant & Cellular Therapy Program (BMTCTP). 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 documents.
Required Qualifications:
- 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.
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