Testing Laboratory Opportunities

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Job Description

Responsible for sample results release, maintenance functions, and 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.

ACCOUNTABILITIES

• Coordinate and perform preventive maintenance on laboratory instrumentation according to Standard Operating Procedures and Instrument User’s Manual.

• Communicate with Laboratory Supervisor to ensure that preventive maintenance is completed within prescribed frequency and timelines.

• Review testing, quality control, and other reports for accuracy, completeness and compliance to requirements to ensure that quality standards are met.

• Release test data to Quality Assurance for batch release.

• Coordinate and release data from the data reduction software for import into the Laboratory Information System.

• Review and verify all necessary actions have been completed prior to export of results to the intermediary database.

• Review and respond to Nonconforming Material Reports received from collection centers.

• Perform entries into the National Donor Deferral System.

• Adheres to the laboratory 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 established corrective action policies and procedures whenever test systems are not within established acceptable levels of performance.

• Document all corrective actions taken when test systems deviate from established performance specifications.

• Performs the duties and responsibilities of a Lab Technician, as needed.

• Coordinate and perform validation of laboratory instrumentation and software according to Standard Operating Procedures, Instrument User’s Manual, validation plans and protocols, under supervision of laboratory and quality management, as needed.

• Document validator and owner.

• CAPA system Non-Conformance Owner and Investigator.

• Participate in operational excellence initiatives and projects to drive a culture of continuous improvement to achieve site operational excellence (including but not limited to 5S, Value Stream Mapping and Kaizen.

• Other duties as assigned. 

Technical/Functional (Line) Expertise

• Occupational exposure to blood borne pathogens.

• Laboratory environment requiring the ability to walk and stand for the entire work shift. 

• Requires frequent lifting up to 25 pounds, and occasional lifting up to 35 pounds.

• Due to potential exposure to blood borne pathogens, 75% of work tasks require prolonged glove wear.

• 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.

• Proficiency in the use of personal computers and software programs including Microsoft Word, Excel, PowerPoint, and Outlook.

Leadership

• Integrity

• Fairness

• Honesty

• Perseverance

• 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.

Interaction

• Interacts with employees of various educational backgrounds and levels within the company.  Must be able to communicate effectively with all these various business partners.

Complexity

• Ability to stand up for 6-8 hours

• Ability to lift, carry and pull up to twenty-five (25) pounds

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor 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.

Desired:

Bachelor degree in medical technology or Associates degree in medical laboratory technology

2-5 years laboratory training or work experience preferred

MT or MLT certification from ASCP or other accredited certifying organization preferred

EEO Statement

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.

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