Quality Control Lab Supervisor

Job Title: Quality Control Lab Supervisor

Department: Laboratory Services

Reports to: Director, Laboratory Services

Risk of Exposure to Bloodborne Pathogens: Yes

Has Direct Reports: Yes

Will be required to drive company vehicle: No

Job Summary

• Oversee the daily operation of the departments.
• Provides guidance and expertise for the laboratory to meet the needs of San Diego Blood Bank (SDBB) customers, in accordance with accepted standards and regulations.
• Assist with coordinating staff schedules, work assignments, and workload.
• Assist with coordinating projects and activities in conjunction with Laboratory Director.
• Assist with interviewing, hiring, and training of new personnel.
• Supports the Lab Management Team, SDBB safety, cGMP and SDBB Quality Plan.
• Participates in department meetings and educational programs.

Responsibilities

• Adheres to current good manufacturing practices (cGMP) guidelines.
• Adheres to CLIA, AABB, CAP, FDA, and other applicable laws, regulations and standards required for laboratory testing.
• Must demonstrate and uphold the SDBB's Standards of Excellence.
• Supervises the flow of samples, blood, and blood components through the department from satellite centers, mobile collection vehicles, hospitals, blood banks, and laboratories.
• Performs platelet production as needed.
• Performs HLA antigen/antibody testing.
• Performs donor and product quality control evaluations.
• Cross-trained in various Immunohematology Reference Laboratory (IRL) essential job duties.
• Performs product labeling and quarantine/disposition of products.
• 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.
• Assists Manager and/or Assistant Manager with staff scheduling if applicable.
• Assists department Trainer with staff training and competency.
• Supervises and adjusts, as needed, the work assignments of staff to best meet the needs of the department and San Diego Blood Bank's operations.
• Maintains communication channels between laboratory areas to ensure a high level of service.
• Provides input on departmental policies and procedures.
• Responsible for reviewing daily records and reports, and taking appropriate action based on the available data.
• Assists with the employee performance evaluations and employee rounding.
• Assists management with counseling, coaching, and disciplining of personnel in accordance with current department and organizational policies and procedures.
• Drafts new or revisions to Standard Operating Procedures, Forms, Job Tools, etc.
• Performs validations and requalifications of equipment.
• Assists with the roll out of new or updated software.
• Keeps management apprised of any situations or circumstances that arise that could have a negative impact on the department or organization's operation.
• Assists with and finalizes Corrective and Preventive Actions (CAPA) investigation, evaluation, root cause(s) and Corrective/Preventative Action Plan.
• Performs supervisory evaluation of deviations, nonconformances or adverse events.
• Assists with department staff meetings and attends other meetings as assigned.
• Enhances professional growth and development of staff and self.
• Supports and complies with San Diego Blood Bank affirmative action policy.
• Assists with all licensed Clinical Laboratory Scientist (CLS) reviews required for the department.
• Embodies and promotes an overall culture of compliance that encourages ethical conduct and a commitment to compliance with laws, regulations, and standards.
• Performs other related duties as assigned or requested.

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.

Physical Requirements

• 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.

Equipment Used

• Standard office equipment including personal computer, faxes, and printers.
• Label printing equipment.
• General laboratory equipment including but not limited to: hematology cell counters, automated hematology analyzers, residual cell analyzers, bacterial detection analyzers, pH meter, pipettes, centrifuges, thermometers, timers, water baths, cell washers, agitators, microscopes, glass viewer, vortex mixers, heat sealers, sterile docking devices, refrigerators/freezers, sterility incubators, tubing strippers, weights, scales, balances, expressors, Thermocyclers, MiniSeq Systems, LABScan 3D, epMotions - if applicable in the laboratory department.
• BECS (Blood Establishment Computer System).

Qualifications

Education:

• Bachelor of Science in Medical Technology or Medical Laboratory Science required; Master of Science preferred.

• Current MLS(ASCP) / MT(ASCP) Certification
• Valid California Clinical Laboratory Scientist License (CLS) is required.
• Specialist in Blood Banking (SBB) Certification preferred.

Experience:

• Minimum 5 years of laboratory experience, including 3 years of supervisory experience.
• Minimum of 5 years of cGMP and regulated work environment experience required.
• Advanced level of understanding of the technical aspects of the laboratory department, blood banking concepts, component manufacturing, and cGMP regulations.
• Advanced knowledge of patient testing, blood donor testing, labeling of components, processing, and quarantine procedures.
• Advanced knowledge of Federal, State, and local government laws, regulations, and statutes related to laboratory testing as well as regulatory agencies licensing requirements.
• Knowledge and application of accreditation standards that apply to blood banking and clinical laboratories (AABB, CAP, and others as applicable).

Skills:

• 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.
• Ability to effectively deal with equipment situations that arise.
• 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.

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.

Pay Range: $120,000 - $148,000 per year