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Form of workJOB SUMMARY
- 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, SDBB safety, cGMP and SDBB Quality Plan.
RESPONSIBILITIES
- Adheres to current good manufacturing practices (cGMP) guidelines.
- Adheres to CUA, AABB, FDA, and other applicable requirements for testing.
- Must demonstrate and uphold the SDBB's Standards of Excellence.
- 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 San Diego Blood Bank's 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.
- Support and comply with SDBB affirmative action policy.
- Perform other related duties as assigned or requested.
Additional Job Accountabilities:
- Supervises daily platelet production, labeling and quarantine/disposition activity.
- Supervises product Quality Control testing, reporting, trending and monthly summary.
- Supervises the Laboratory Quality Control, maintenance and validation processes.
- Assist Manager and/or Assistant Manager with staff scheduling and controlled document writing.
- Assist department Trainer with staff training and competency.
- Assist Management with equipment calibrations and periodic NIST - certifications for QC Lab
WORKING ENVIRONMENT
- Normal laboratory environment with biohazard precautions.
- May be exposed to the risk of blood borne diseases.
- May be exposed to chemicals that may be hazardous.
- May be called on to work or attend meetings at other than routinely scheduled hours.
- Must be able to perform physical laboratory procedures when necessary.
- Must be able to work on a computer 4 - 8 hours a day.
- Must be able to move around office and attend meetings outside of office.
- Ability to travel to other SDBB sites as needed.
- Standard office equipment including personal computer, faxes and printers.
- Label printing equipment.
- General laboratory equipment including but not limited to: hematology cell counters, residual cell counters, bacterial detection analyzers, pH meter, centrifuges, water baths, cell washers, timers, microscopes, glass viewer, heat sealers, sterile docking devices, refrigerators/freezers, sterility incubators, tubing strippers, weights, scales, balances, expressors -if applicable in the lab department.
- BEGS (Blood Establishment Computer Systems)
QUALIFICATIONS
- 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.
- Interpersonal skills to establish and maintain professional relationships.
- Professional communication both written and oral, which is clear and precise.
- Integrity and discretion - ability to maintain confidentiality and cGMP compliance.
- Ability to perform under pressure and work under stressful situations.
- Critical thinking, creativity and innovation.
- Decision-making skills. Uses authority appropriately in making sound judgments in a timely manner. Accepts accountability.
- Flexibility - ability to effectively manage change and positively influence others.
Education:
- Bachelor of Science preferred but not required
Experience:
- Minimum 2 years in blood bank related fields to include leadership experience (laboratory, supervisory and/or regulatory) and IRL experience, if applicable to department.
Certifications/Licenses:
- MLS(ASCP)Cm / MT(ASCP), or equivalent experience
- California Clinical Laboratory Scientist License (CLS) preferred
- Specialist in Blood Banking (SBB) or equivalent education preferred
The above statements are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
