- Oversee the daily operation of the department.
- Assist with coordinating staff schedules, work assignments, and workload.
- Assist with coordinating projects and activities in conjunction with department Manager.
- Assist with interviewing, hiring, and training of new personnel.
- Supports the Lab Management Team, safety, cGMP and Quality Plan.
- Adheres to current good manufacturing practices (cGMP) guidelines.
- Adheres to CUA, AABB, FDA, and other applicable requirements for testing.
- Supervise the flow of samples, blood, and blood components through the department from satellite centers, mobile collection vehicles, hospitals, blood banks, and laboratories.
- Supervise and adjust, as needed, the work assignments of staff to best meet the needs of the department and operations.
- Maintain communication channels between lab areas to ensure a high level of service.
- Provide input on departmental policies and procedures.
- Responsible for reviewing daily records and reports, and taking the appropriate action based on the available data.
- Ability to work with a variety of temperature monitoring systems and effectively deal with equipment situations that arise.
- Assist with the employee performance evaluations and rounding for staff.
- Conduct counseling, coaching and disciplining of personnel in accordance with current department and organizational policies and procedures.
- Assist management by drafting new or revisions to controlled documents.
- Assist management with validations and re-qualifications of equipment.
- Assist with the roll out of new or updated software.
- Keep management apprised of any situations or circumstances that arise that could have a negative impact on the department or organization's operation.
- Finalize investigation, evaluation, CAPA and final review for quality and error events.
- Perform supervisory evaluation of QIRs.
- Oversee Q&D process for lab.
- Assist with department staff meetings and attend other meetings as assigned.
- Enhance professional growth and development of staff and self.
- Perform other related duties as assigned or requested.
- Perform daily QIR and QD activity for department.
- Coordinate daily patient case work load and prioritization.
- Assist Management with the Laboratory quality control, maintenance and validation processes.
- Assist Management with controlled document writing, staff scheduling, and equipment and process validations.
- Assist Management with staff training and competency.
- Assist with all CLS reviews required for the department
- Advanced level of understanding of the technical aspects of the lab department, blood banking concepts, component manufacturing, and cGMP regulations.
- Knowledge and application of standards and regulations that apply to blood banking (FDA, AABB, OSHA, SOS, and others as needed).
- Must be keenly detail-oriented, well-organized, self-motivated, flexible and capable of independent work with changing priorities, and display good time management skills.
- Must be able to direct workflow and perform advanced troubleshooting of scientifically technical problems.
- Bachelor of Science required
- Minimum 2 years in blood bank related fields to include leadership experience (laboratory, supervisory and/or regulatory) and IRL experience, if applicable to department.
- MLS(ASCP)Cm / MT(ASCP) or equivalent experience
- California Clinical Laboratory Scientist License (CLS) required
- Specialist in Blood Banking (SBB) or equivalent, preferred
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