Responsible for the technical and operational oversight of their various labs in accordance with established Standing 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. They serve as CLIA Technical Supervisor and Director Designee.
Plan and direct testing activities of BioLife Testing Laboratories (BTL-US) by performing the following duties personally or through subordinate supervisors as allowed per regulations.
Directly supervises Laboratory Supervisors and testing personnel and provides technical assistance to testing personnel performing high and moderate complexity testing, and to donor centers as it relates to laboratory related issues.
Interviews, hires and supervises the performance of their laboratory staff. Organizes and prioritizes workloads and assignments in conjunction with business requirements.
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, ensuring that quality standards, efficiency and schedules are met.
Provides leadership in problem identification, investigation and resolution throughout the laboratory.
Works in conjunction with Laboratory Quality personnel in implementation, monitoring and maintenance of the laboratory quality systems, and result release.
Oversees testing, equipment and sample management functions to ensure accuracy and that sample testing is performed, completed and reported in a timely manner.
Evaluates laboratory systems, processes, procedures and equipment as they relate to operating efficiency, effectiveness and regulatory compliance.
Other duties as assigned
The following are duties that may be designated by CLIA Director to Technical Supervisor:
The technical supervisor is not required to be on site at all times testing is performed, however they must be available to the laboratory as needed to provide on-site, telephone, or electronic consultation and supervision.
Evaluate/select test methodology that is appropriate and capable of providing the quality of results; and ensure verification of the test procedures and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.
Resolve technical problems and ensures that remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications. Ensures that test results are not reported until all corrective actions have been taken and the test system is functioning properly.
Identifies training needs and assuring that each individual performing tests has been appropriately trained and receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. Also ensures competency evaluation of all testing personnel and assures that staff maintains their competency to perform their job functions.
Ensures an approved and current procedure manual is available to all personnel. 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 manufacturer inserts. Review of SOPs is performed and changes are implemented in a timely manner.
Establish a quality control program appropriate for testing performed and establish parameters for acceptable levels of analytic performance ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and result reporting.
Ensures the enrollment and participation in an HHS approved proficiency testing (PT) program commensurate with the services offered.
Ensures PT samples are tested in accordance with the CLIA requirements, PT results are returned within the time frames established by PT program, PT reports are reviewed by the appropriate staff and corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory.
Technical/Functional (Line) Expertise
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.
Demonstrate work history of above average performance and attendance.
Excellent interpersonal skills and communication skills including written, verbal and oral presentations.
Result oriented with ability to adapt to changing priorities.
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.
Walking, standing, observing others performing work assignments.
Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, leaning.
Ability to work in an office / production environment.
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy
Must be able to determine impact to product quality when testing deviations occur, contain the situation and implement preventive actions.
Interfaces with employees of various educational backgrounds and levels within the company. Must be able to communicate effectively with all these various business partners.
Ability to stand up for 6-8 hours
Ability to lift, carry and pull up to twenty-five (25) pounds
Potential exposure to blood borne pathogens requires some work tasks to be performed while wearing gloves.
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.
Some travel may be required
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and have at least 3 years of laboratory training or experience, or both, in high complexity testing,
Bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and have at least 5 years of laboratory training or experience, or both, in high complexity testing.
3 to 5 years’ experience in a professional or technical capacity 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 or more year’s management experience preferred.
MT or MLT certification from ASCP or other accredited certifying organization preferred
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.