Responsible for performing testing 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.
Perform only high and moderate complexity tests for which certification has been authorized by the laboratory director or designee and deemed commensurate with their education, training, and technical abilities.
Responsible for sample management, test performance, quality control, result review, result reporting and equipment maintenance such that accurate and appropriate sample testing is performed, completed, and reported in a timely manner.
Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records of donor test results.
Test and maintain records that demonstrate proficiency testing samples are tested in the same manner as donor samples.
Adhere to the laboratory’s quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.
Identify problems that may adversely affect test performance or reporting of test results and either correct the problems or immediately notify the laboratory management.
Follow the laboratory’s established corrective action policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance.
Document all corrective actions taken when test systems deviate from the laboratories established performance specifications.
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).
Other duties as assigned.
Technical/Functional (Line) Expertise
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records
Excellent written and verbal communication skills, interpersonal skills and analytical/problem solving skills
Proficiency in the use of personal computers and applicable software
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 90% of work tasks to be performed while wearing gloves
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor’s degree from an accredited college/university in a biomedical discipline (Chemical, physical, biological, clinical lab science, or medical technology,) OR
Associate degree from an accredited college/university in laboratory science or medical laboratory technology
Bachelor’s degree in medical technology or Associates degree in medical laboratory technology
1-year laboratory training or work 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.