1.Manages the day-to-day supervision of Laboratory Support Services.
2.Directly supervises Sample Logistics Supervisor, Facility Supervisor, Laboratory Office, Administrative personnel and other support staff.
3.Must be accessible to support 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.
4.Provide daily supervision of result release performance by qualified testing personnel.
5.Monitors test analyses to ensure that acceptable levels of analytic performance are maintained.
6.Interviews, hires, and supervises performance of laboratory staff under the oversight of CLIA Laboratory Director and/or Technical Supervisor.
7.Ensures that proper training is received and documented under the oversight of CLIA Laboratory Director and/or Technical Supervisor.
8.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.
9.Oversee release of test data to Quality Assurance for batch release.
10.Provide technical assistance to staff, operations, and donor centers in laboratory related issues.
11.Organize and prioritize workloads and assignments in conjunction with donor center requirements.
12.Participates in evaluation of new equipment and methodologies.
13.Evaluates laboratory systems, processes, procedures and equipment as they relate to operating efficiency, effectiveness and regulatory compliance.
14.Advises Director of Operations, Quality Assurance Manager and technical personnel of laboratory support activities.
15.Works in conjunction with Laboratory Quality Assurance Manager in the implementation, monitoring, and maintenance of the laboratory quality systems.
16.Performs periodic review of SOPs and changes are implemented in a timely manner.
17.Ensures all procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines. SOP manuals contain current versions of procedures and manufacturer inserts.
18.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, Developing Defect Free Processes (DDFP) and Leading Daily Improvement (LDI)).
Duties CLIA Director and Technical Supervisor delegate to Laboratory Services Manager:
1.Assure that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
2.Ensure that test results are not reported until all corrective actions have been taken and the test system is properly functioning.
3.Provide orientation to area personnel.
4.Annually evaluate and document the performance of testing and support personnel.
All other duties as assigned.
EDUCATION AND EXPERIENCE
Minimum Degree Required:
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 5 years of laboratory training or experience in high complexity testing,
Associate’s degree in a laboratory science or medical laboratory technology, and at least 7 years of laboratory training or experience in high complexity testing.
Bachelor’s degree or higher from an accredited college/university in medical technology.
- MT/MLT Certification Preferred
- Five to seven years of professional or technical experience in a laboratory, blood services or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.
- Familiarity with regulated disciplines in a blood bank setting or a pharmaceutical manufacturing environment.
- 3-5 years management experience required.
KNOWLEDGE, SKILLS AND ABILITY:
- Excellent interpersonal skills and communication skills including written, verbal and oral presentations.
- Attention to detail and organizational skills with analytical and problem solving skills.
- Proficiency in the use of personal computers and software programs including Microsoft Word, Excel and PowerPoint.
- Ability to adapt to changing priorities.
- Walking, standing, observing others performing work assignments.
- Office / Production environment.
- Occupational exposure to blood borne pathogens.
- The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.