Responsible for the operation of Sample Logistics 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 sample logistics, pre-analytic operations, and all personnel in their laboratory area.
Provides assistance to staff, operations, and donor centers for issues related to sample logistics.
Organize and prioritize workloads and assignments in conjunction donor center requirements.
Assures all remedial actions are taken whenever systems deviate from the laboratory's established performance specifications.
Evaluates applicable laboratory systems, processes, procedures and equipment as they relate to operating efficiency and effectiveness.
Provides supervisory expertise to projects requiring logistics support and evaluation.
Advises Director of Operations, Quality Assurance Manager, and technical personnel of sample logistics activities.
Performs sample logistics functions, if needed.
Ensures proper training is received and documented; provides orientation to all Sample Logistics personnel; and annually evaluates and documents the performance of personnel.
Interviews, hires, and supervises performance of Sample Logistics staff under oversight of the Laboratory Services Manager.
Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems.
Ensures that all procedures related to laboratory equipment are current, periodically reviewed, 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 and Kaizen.)
Performs frequent visits to operational areas to drive organizational alignment and process focus by actively completing periodic Layered Standardized Gemba Walks.
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.
Interfaces with employees of various educational backgrounds and levels within the company. Must be able to communicate effectively with all these various business partners.
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.
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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor degree or higher from an accredited college/university in a bioscience discipline (Chemical, physical, biological, clinical lab science, or medical technology,) and at least 1 year of Supervisory experience.
Associate’s degree in a laboratory science or medical laboratory technology, and at least 2 years of laboratory training or experience and 3 years Supervisory experience.
HS Diploma and 10 years Supervisory experience
Bachelor’s degree or higher from an accredited college/university in medical technology
5-7 years lab experience
Experience in supervising or training others is highly desirable.
Technical/Professional certification as applicable.
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.