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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 will inspire and empower you to grow through life-changing work. We are certified as a Global Top Employer and offer stimulating careers, encourage innovation, and strive 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.

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 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 (CUA), and applicable Takeda and BioLife policies, procedures, and quality initiatives.

ACCOUNTABILITIES

+ Coordinate and perform preventive maintenance on laboratory instrumentation according to StandardOperatingProceduresandInstrumentUser'sManual.(5%}

+ 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 with requirementsto ensure that qualitystandardsare met.(10%}

+ Release test data to Quality Assurance for batch release. (10%}

+ Coordinate and release data from the data reduction software for import into the Laboratory Information System. (10%}

+ Review and verify all necessary actions have been completed prior to export of results to the intermediarydatabase.(10%}

+ Review and respond to Nonconforming Material Reports received from collection centers. (5%}

+ Perform entries into the National Donor Deferral System.(5%}

+ Adheres to the laboratory quality control policies, documents all quality control activities, instrument and procedural calibrations, and maintenance performed. (10%}

+ Identify problems that may adversely affect test performance or the reporting of test results and either correct the problems or immediately notify the laboratory management. (10%}

+ 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. (5%}

+ 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. (5%}

+ Document validator and owner.(5%}

+ CAPA system Non-Conformance Owner and Investigator. (5%}

+ 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. (5%)

+ Other duties as assigned.

_DIMENSIONS AND_** **_ASPECTS_

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

+ Perserverance

+ 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

+ 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:_

Essential:

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.

Desired:

Bachelor's degree in medical technology or an Associate's degree in medical laboratory technology, 2-5 years of laboratory training or work experience 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

$20.53 - $32.26

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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

No