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.
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.
Provides 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.
Participates 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.
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.
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.
Interacts 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
Ability of Walking, standing, observing others performing work assignments.
Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, leaning
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Occupational exposure to blood borne pathogens.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
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.
Associate’s degree in a laboratory science or medical laboratory technology, and at least 5 years of laboratory training or experience.
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 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.