Senior Laboratory Technician

Location: Madison

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Job Description About Bio Life 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 Bio Life, 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 Bio Life 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. Bio Life 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 Bio Life policies, procedures, and quality initiatives.

ACCOUNTABILITIES
* Coordinate and perform preventive maintenance on laboratory instrumentation according to Standard Operating Procedures and Instrument User's Manual. (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 requirements to ensure that quality standards are 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 intermediary database. (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…