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Job Description

About Us:

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 centers and most importantly our commitment to our patients is expected.

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

What Takeda can offer you:

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.

More about us:

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 will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, 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.

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.

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.

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

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.

OR

Associate’s degree in a laboratory science or medical laboratory technology, and at least 5 years of laboratory training or experience.

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

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:

USA - GA - Social Circle - Baxter Pkwy

$86,500.00 - $135,960.00

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.

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._

Locations

USA - GA - Social Circle - Baxter Pkwy

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes