Laboratory Supervisor - Donor Qualification 2nd Shift

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Job Description

The Laboratory Operations Supervisor is responsible for the operation of their  laboratory area in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable Takeda and BioLife policies, procedures and quality initiatives. 

Essential Functions

Responsibilities

• Provides day-to-day supervision of all laboratory operations and moderate or high complexity testing performance in their laboratory area. 
  • Functions as supervisor for testing personnel performing high and moderate complexity testing.  Organize and prioritize workloads and assignments in conjunction with donor center requirements.
  • Responsible for maintaining reagent and consumable inventory.
  • Performs annual employee performance reviews and employee counseling.  Performs and reviews pre-analytical staff training and competency assessments.  Ensures proper training is received under oversight of Operations Manager and CLIA Laboratory Director.
  • Provide technical assistance to staff, operations, and donor centers in laboratory related issues
  • Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in  accordance with policies and procedures established either by the laboratory director or technical supervisor.

• Performs NCMR, ENC and CAPA functions. 
• Evaluates laboratory systems, processes, procedures and equipment as they relate to operating efficiency, effectiveness and regulatory compliance.  Participates in the evaluation of new tests and methodologies.
• Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems.
• Ensures periodic review of SOPs is performed and changes are implemented in a timely manner.  Ensures that all procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines.
• Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence goals (including but not limited to 5S, Value Stream Mapping, Kaizen, Layered Standardized Gemba Walks). 
• Monitors test analyses to ensure that acceptable levels of analytic performance are maintained.  Reviews testing, quality control, and other testing reports for accuracy, completeness and compliance to requirements to ensure that quality standards, efficiency, and schedules are met.
• Other duties as assigned.

Education & Experience Requirements

• Bachelor’s degree or higher from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology,) and at least 3 years of laboratory training or experience.

                                     OR

• Associate’s degree in a laboratory science or medical laboratory technology, and at least 5 years of laboratory training or experience.

Desired:

• Bachelor’s degree or higher from an accredited college/university in medical technology
• Previous supervisory experience in a laboratory setting preferred
• MT or MLT certification