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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.

Role Overview:

Responsible for the operation of the laboratory 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.

Performs quality assurance activities of BioLife Testing laboratory by performing the following duties.

_ACCOUNTABILITIES_

Reviews testing, quality control, and other testing reports for accuracy,** **completeness and compliance to cGMP requirements** **to ensure that quality assurance standards and regulatory requirements are met prior to release from the Quality Assurance Department.

Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system processes in order to effectively perform laboratory quality assurance functions.

Adheres to the laboratory quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.

Identifies 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 review and or validation of SOPs as needed.

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, and Kaizen.

Other duties as assigned.

Technical/Functional (Line) Expertise

Strong knowledge and understanding of applicable regulatory and quality requirements and standards.

Strong written, verbal, personal interaction and communication skills required.

Must be able to write concisely and clearly.

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.

Result oriented with ability to adapt to changing priorities.

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

Interfaces 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

Walking, standing, observing others performing work assignments.

Potential exposure to blood borne pathogens requires some work tasks to be performed while wearing gloves.

Ability to work in an office / production environment.

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.

_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,)

OR

Associate degree from an accredited college/university in laboratory science or medical laboratory technology.

Desired:

Minimum of two years’ experience in a professional or technical capacity in laboratory services, blood services, quality, or pharmaceutical manufacturing, including significant exposure to the regulatory requirements affecting that discipline or activity.

Technical/Professional** **certification preferred.

Prior experience with auditing and/or inspection processes 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 - AL - Hoover

$18.85 - $29.62

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 - AL - Hoover

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No