Quality Assurance Opportunities

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Job Description

Takeda has maintained an unwavering dedication to put patients first for more than 235 years while we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

We focus our research and development on the core therapeutic areas of oncology, gastroenterology, neuroscience, and on providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

BioLife, a subsidiary of Takeda, is an industry leader in operating high quality plasmapheresis centers throughout the United States. At BioLife Plasma Services, we excel at caring. Caring for the quality of our lifesaving services, caring for the donors who help make it happen, and caring for the communities we call home. Improving Lives. Improving life for everyone. BioLife’s employment opportunities are among the best, offering competitive pay, immediate benefits, paid time off, on the job training, advancement potential AND an environment full of fast-paced fun all while working to save lives.

Primary Role

To assist lab staff and management as needed in jobs (preanalytical in nature) that do not require performance by testing personnel 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.

Essential Functions

Responsibilities

• Perform sample receiving/accessioning/processing according to SOP.

• Perform sample centrifugation according to SOP as applicable to assigned area.

• Responsible for discarding samples.

• Request and receive back-up samples if applicable to assigned area.

• Perform equipment maintenance and sample management functions to ensure accuracy and appropriate sample processing is performed and completed so testing is performed in a timely manner.

• Daily communication of issues related to laboratory equipment, supplies, workload scheduling and participation in continuous improvement activities. Interactions involve basic courtesy, tact and respect.

• Non-technical duties include monitoring supply inventories, ensuring that supply bins on the Lab floor are adequately stocked, and that work area is maintained in a compliant state, equipment and instrumentation is cleaned in accordance with SOPs.

• Participate 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 and Developing Defect Free Processes (DDFP).

• Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.

• Other duties as assigned.

Education & Experience Requirements

• High School diploma or equivalent required.

Desired:

Previous work experience in a Lab setting is preferred

Key Skills and Competencies

• 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 communication and interpersonal skills, analytical and problem solving skills and be detail/result oriented.

• 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 30 pounds, and occasional lifting up to 35 pounds.

• Due to potential exposure to blood borne pathogens, 90% 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.

Other Job Components

• Must be able to determine impact to product quality when testing deviations occur, contain the situation and implement preventive actions.

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

• Ability to stand up for 6 - 8 hours

• Ability to lift, carry, pull up to thirty (30) pounds.

BioLife Compensation and BenefitsSummary

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. Hourly Wage Range:

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