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Job Description

About BioLife Plasma

Takeda offers a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work. We are certified as a Global Top Employer, offering stimulating careers, encouraging innovation, and striving for excellence in everything we do. We foster an inclusiveand collaborative workplace in which our teams are united by an unwavering commitment to bring Better Health and a brighter future to people around the world.

Every day, our BioLife Testing Laboratories' mission is to ensure the highest quality testing standards for the plasma we collect. The plasma our centers collect will become life-changing medicines for patients in need. Here, a commitment to lab testing quality, customer service to our plasma centers, and most importantly, our commitment to our patients is expected.

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

OBJECTIVES/PURPOSE
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.

ACCOUNTABILITIES

• Provides day-to-day supervision of all laboratory operations and moderate or high complexity testing performance in their laboratory area. (50%)
• Functions as a 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 the oversight of the Operations Manager and theCLIA 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. (10%)
• 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.(5%)
• Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems. (10%)
• 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. (10%)
• 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). (5%)
• Monitors test analyses to ensure that acceptable levels of analytic performance are maintained. Review testing, quality control, and other testing reports for accuracy, completeness, and compliance with requirements to ensure that quality standards, efficiency, and schedules are met (10%)
• Other duties as assigned.

The following are duties that may be designated by the CLIA Director to the General Supervisor:

• Remedial actions are taken when test systems deviate from the laboratory's established performance specifications;
• Patient test results are not reported until all corrective actions have been taken and the test system functions properly;
• Orientation is provided to all testing personnel; and
• Annual personnel performance evaluations and documentation of testing personnel performance competency.

The following are duties that may be designated by the CLIA Director to the Technical Supervisor or the Technical Consultant:

• 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 ensure 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 ensures 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 maintain 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 the current versions of 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 the 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.

DIMENSIONS AND ASPECTS

• 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 the 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. DocuSign Envelope ID: C4114D65-81EF-490D-B98D-0D0E13DBE0A6

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 the impact on product quality when testing deviations occur, contain the situation, and implement preventive actions.
• Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships)
• 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
• Ability to walk, stand, and observe others performing work assignments.
• Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, and 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:

Essential:

• Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical, or medical laboratory science, or medical technology, or nursing from an accredited institution;
• Or have earned an associate degree in a chemical, biological, clinical, or medical laboratory science, or medical laboratory technology, or nursing from an accredited institution

Desired:

• 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

ADDITIONAL INFORMATION

• FLSA Classification (US) - Exempt

BioLife Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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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Job Exempt