6 jobs found

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 inspires and empowers you to grow through life-changing work. We are certified as a Global Top Employer, offering stimulating careers, encouraging innovation, and striving for excellence in everything we do. We foster an inclusive and 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 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. (50%) Functions as a 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 the oversight of the Operations Manager and the 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. (10%) 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.(5%) Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems. (10%) 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. (10%) 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). (5%) Monitors test analyses to ensure that acceptable levels of analytic performance are maintained. Review testing, quality control, and other testing reports for accuracy, completeness, and compliance with requirements to ensure that quality standards, efficiency, and schedules are met (10%) Other duties as assigned. The following are duties that may be designated by the CLIA Director to the General Supervisor: Remedial actions are taken when test systems deviate from the laboratory's established performance specifications; Patient test results are not reported until all corrective actions have been taken and the test system functions properly; Orientation is provided to all testing personnel; and Annual personnel performance evaluations and documentation of testing personnel performance competency. The following are duties that may be designated by the CLIA Director to the Technical Supervisor or the Technical Consultant: Evaluate/select test methodology that is appropriate and capable of providing the quality of results; and ensure verification of the test procedures and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. Ensures that test results are not reported until all corrective actions have been taken and the test system is functioning properly. Identifies training needs and ensures that each individual performing tests has been appropriately trained and receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. Also ensures competency evaluation of all testing personnel and assures that staff maintain their competency to perform their job functions. Ensures an approved and current procedure manual is available to all personnel. All procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines. SOP manuals contain the current versions of manufacturer inserts. Review of SOPs is performed and changes are implemented in a timely manner. Establish a quality control program appropriate for testing performed and establish parameters for acceptable levels of analytic performance, ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and result reporting. Ensures the enrollment and participation in an HHS-approved proficiency testing (PT) program commensurate with the services offered. Ensures PT samples are tested in accordance with the CLIA requirements, PT results are returned within the time frames established by the PT program, PT reports are reviewed by the appropriate staff, and corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory. DIMENSIONS AND ASPECTS 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 the 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. DocuSign Envelope ID: C4114D65-81EF-490D-B98D-0D0E13DBE0A6 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 the impact on product quality when testing deviations occur, contain the situation, and implement preventive actions. Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships) 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 to walk, stand, and observe others performing work assignments. Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, and 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: Essential: Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical, or medical laboratory science, or medical technology, or nursing from an accredited institution; Or have earned an associate degree in a chemical . click apply for full job details

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 inspires and empowers you to grow through life-changing work. We are certified as a Global Top Employer, offering stimulating careers, encouraging innovation, and striving for excellence in everything we do. We foster an inclusive and 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 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. (50%) Functions as a 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 the oversight of the Operations Manager and the 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. (10%) 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.(5%) Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems. (10%) 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. (10%) 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). (5%) Monitors test analyses to ensure that acceptable levels of analytic performance are maintained. Review testing, quality control, and other testing reports for accuracy, completeness, and compliance with requirements to ensure that quality standards, efficiency, and schedules are met (10%) Other duties as assigned. The following are duties that may be designated by the CLIA Director to the General Supervisor: Remedial actions are taken when test systems deviate from the laboratory's established performance specifications; Patient test results are not reported until all corrective actions have been taken and the test system functions properly; Orientation is provided to all testing personnel; and Annual personnel performance evaluations and documentation of testing personnel performance competency. The following are duties that may be designated by the CLIA Director to the Technical Supervisor or the Technical Consultant: Evaluate/select test methodology that is appropriate and capable of providing the quality of results; and ensure verification of the test procedures and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. Ensures that test results are not reported until all corrective actions have been taken and the test system is functioning properly. Identifies training needs and ensures that each individual performing tests has been appropriately trained and receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. Also ensures competency evaluation of all testing personnel and assures that staff maintain their competency to perform their job functions. Ensures an approved and current procedure manual is available to all personnel. All procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines. SOP manuals contain the current versions of manufacturer inserts. Review of SOPs is performed and changes are implemented in a timely manner. Establish a quality control program appropriate for testing performed and establish parameters for acceptable levels of analytic performance, ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and result reporting. Ensures the enrollment and participation in an HHS-approved proficiency testing (PT) program commensurate with the services offered. Ensures PT samples are tested in accordance with the CLIA requirements, PT results are returned within the time frames established by the PT program, PT reports are reviewed by the appropriate staff, and corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory. DIMENSIONS AND ASPECTS 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 the 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. DocuSign Envelope ID: C4114D65-81EF-490D-B98D-0D0E13DBE0A6 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 the impact on product quality when testing deviations occur, contain the situation, and implement preventive actions. Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships) 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 to walk, stand, and observe others performing work assignments. Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, and 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: Essential: Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical, or medical laboratory science, or medical technology, or nursing from an accredited institution; Or have earned an associate degree in a chemical . click apply for full job details

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 inspires and empowers you to grow through life-changing work. We are certified as a Global Top Employer, offering stimulating careers, encouraging innovation, and striving for excellence in everything we do. We foster an inclusive and 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 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. (50%) Functions as a 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 the oversight of the Operations Manager and the 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. (10%) 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.(5%) Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems. (10%) 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. (10%) 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). (5%) Monitors test analyses to ensure that acceptable levels of analytic performance are maintained. Review testing, quality control, and other testing reports for accuracy, completeness, and compliance with requirements to ensure that quality standards, efficiency, and schedules are met (10%) Other duties as assigned. The following are duties that may be designated by the CLIA Director to the General Supervisor: Remedial actions are taken when test systems deviate from the laboratory's established performance specifications; Patient test results are not reported until all corrective actions have been taken and the test system functions properly; Orientation is provided to all testing personnel; and Annual personnel performance evaluations and documentation of testing personnel performance competency. The following are duties that may be designated by the CLIA Director to the Technical Supervisor or the Technical Consultant: Evaluate/select test methodology that is appropriate and capable of providing the quality of results; and ensure verification of the test procedures and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. Ensures that test results are not reported until all corrective actions have been taken and the test system is functioning properly. Identifies training needs and ensures that each individual performing tests has been appropriately trained and receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. Also ensures competency evaluation of all testing personnel and assures that staff maintain their competency to perform their job functions. Ensures an approved and current procedure manual is available to all personnel. All procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines. SOP manuals contain the current versions of manufacturer inserts. Review of SOPs is performed and changes are implemented in a timely manner. Establish a quality control program appropriate for testing performed and establish parameters for acceptable levels of analytic performance, ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and result reporting. Ensures the enrollment and participation in an HHS-approved proficiency testing (PT) program commensurate with the services offered. Ensures PT samples are tested in accordance with the CLIA requirements, PT results are returned within the time frames established by the PT program, PT reports are reviewed by the appropriate staff, and corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory. DIMENSIONS AND ASPECTS 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 the 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. DocuSign Envelope ID: C4114D65-81EF-490D-B98D-0D0E13DBE0A6 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 the impact on product quality when testing deviations occur, contain the situation, and implement preventive actions. Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships) 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 to walk, stand, and observe others performing work assignments. Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, and 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: Essential: Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical, or medical laboratory science, or medical technology, or nursing from an accredited institution; Or have earned an associate degree in a chemical . click apply for full job details

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 inspires and empowers you to grow through life-changing work. We are certified as a Global Top Employer, offering stimulating careers, encouraging innovation, and striving for excellence in everything we do. We foster an inclusive and 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 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. (50%) Functions as a 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 the oversight of the Operations Manager and the 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. (10%) 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.(5%) Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems. (10%) 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. (10%) 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). (5%) Monitors test analyses to ensure that acceptable levels of analytic performance are maintained. Review testing, quality control, and other testing reports for accuracy, completeness, and compliance with requirements to ensure that quality standards, efficiency, and schedules are met (10%) Other duties as assigned. The following are duties that may be designated by the CLIA Director to the General Supervisor: Remedial actions are taken when test systems deviate from the laboratory's established performance specifications; Patient test results are not reported until all corrective actions have been taken and the test system functions properly; Orientation is provided to all testing personnel; and Annual personnel performance evaluations and documentation of testing personnel performance competency. The following are duties that may be designated by the CLIA Director to the Technical Supervisor or the Technical Consultant: Evaluate/select test methodology that is appropriate and capable of providing the quality of results; and ensure verification of the test procedures and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. Ensures that test results are not reported until all corrective actions have been taken and the test system is functioning properly. Identifies training needs and ensures that each individual performing tests has been appropriately trained and receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. Also ensures competency evaluation of all testing personnel and assures that staff maintain their competency to perform their job functions. Ensures an approved and current procedure manual is available to all personnel. All procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines. SOP manuals contain the current versions of manufacturer inserts. Review of SOPs is performed and changes are implemented in a timely manner. Establish a quality control program appropriate for testing performed and establish parameters for acceptable levels of analytic performance, ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and result reporting. Ensures the enrollment and participation in an HHS-approved proficiency testing (PT) program commensurate with the services offered. Ensures PT samples are tested in accordance with the CLIA requirements, PT results are returned within the time frames established by the PT program, PT reports are reviewed by the appropriate staff, and corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory. DIMENSIONS AND ASPECTS 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 the 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. DocuSign Envelope ID: C4114D65-81EF-490D-B98D-0D0E13DBE0A6 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 the impact on product quality when testing deviations occur, contain the situation, and implement preventive actions. Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships) 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 to walk, stand, and observe others performing work assignments. Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, and 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: Essential: Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical, or medical laboratory science, or medical technology, or nursing from an accredited institution; Or have earned an associate degree in a chemical . click apply for full job details

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 inspires and empowers you to grow through life-changing work. We are certified as a Global Top Employer, offering stimulating careers, encouraging innovation, and striving for excellence in everything we do. We foster an inclusive and 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 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. (50%) Functions as a 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 the oversight of the Operations Manager and the 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. (10%) 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.(5%) Works in conjunction with Laboratory Quality Assurance Management in the implementation, monitoring, and maintenance of the laboratory quality systems. (10%) 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. (10%) 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). (5%) Monitors test analyses to ensure that acceptable levels of analytic performance are maintained. Review testing, quality control, and other testing reports for accuracy, completeness, and compliance with requirements to ensure that quality standards, efficiency, and schedules are met (10%) Other duties as assigned. The following are duties that may be designated by the CLIA Director to the General Supervisor: Remedial actions are taken when test systems deviate from the laboratory's established performance specifications; Patient test results are not reported until all corrective actions have been taken and the test system functions properly; Orientation is provided to all testing personnel; and Annual personnel performance evaluations and documentation of testing personnel performance competency. The following are duties that may be designated by the CLIA Director to the Technical Supervisor or the Technical Consultant: Evaluate/select test methodology that is appropriate and capable of providing the quality of results; and ensure verification of the test procedures and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications. Ensures that test results are not reported until all corrective actions have been taken and the test system is functioning properly. Identifies training needs and ensures that each individual performing tests has been appropriately trained and receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. Also ensures competency evaluation of all testing personnel and assures that staff maintain their competency to perform their job functions. Ensures an approved and current procedure manual is available to all personnel. All procedures related to laboratory equipment are current, have maintenance and quality control steps, and reflect applicable manufacturer operating requirements and guidelines. SOP manuals contain the current versions of manufacturer inserts. Review of SOPs is performed and changes are implemented in a timely manner. Establish a quality control program appropriate for testing performed and establish parameters for acceptable levels of analytic performance, ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and result reporting. Ensures the enrollment and participation in an HHS-approved proficiency testing (PT) program commensurate with the services offered. Ensures PT samples are tested in accordance with the CLIA requirements, PT results are returned within the time frames established by the PT program, PT reports are reviewed by the appropriate staff, and corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory. DIMENSIONS AND ASPECTS 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 the 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. DocuSign Envelope ID: C4114D65-81EF-490D-B98D-0D0E13DBE0A6 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 the impact on product quality when testing deviations occur, contain the situation, and implement preventive actions. Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships) 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 to walk, stand, and observe others performing work assignments. Performing and demonstrating work assignments, which may involve lifting, bending, stooping, sitting, and 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: Essential: Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical, or medical laboratory science, or medical technology, or nursing from an accredited institution; Or have earned an associate degree in a chemical . click apply for full job details

B. Braun Medical, Inc. Company: B. Braun US Pharmaceutical Manufacturing LLC Job Posting Location: Irvine, California, United States Functional Area: Quality Working Model: Onsite Days of Work: Friday, Thursday, Wednesday, Tuesday, Monday Shift: 3/4 X 12 Relocation Available: No Requisition ID: 7753 B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS . Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit Position Summary: Perform routine laboratory analysis of In-Process, finished product, raw material, stability samples and environmental monitoring according to established specifications and procedures using wet chemistry techniques or various laboratory apparatus and instruments (e.g. HPLC, UV/Visible Spectrophotometer, FTIR, TOC, pH meter etc.) in compliance with B. Braun, cGMP, GLPs, SOPs, USP and FDA guidelines. Responsibilities: Essential Duties • Performs routine laboratory analysis of in Process, finished product, raw material, stability samples and environmental monitoring according to established specifications and procedures using wet chemistry techniques or various laboratory apparatus and instruments (e.g. HPLC, UV/Visible Spectrophotometer, FTIR, TOC, pH meter etc.) in compliance with B. Braun, cGMP, GLPs, SOPs, USP and FDA guidelines. • Performs routine qualification, calibration and maintenance of laboratory instruments. • Prepares analytical standards and reagents according to established procedures and specifications. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons. Expertise: Knowledge & Skills Assignments are routine and repetitious in nature. Work performed within narrowly defined parameters. Follows established procedures and guidelines. Works under direct supervision and from detailed verbal and/or written instructions. Uses established procedures to accomplish assigned task. May require some limited judgement in resolving problems. Contacts are primarily with direct supervisor, peers and subordinates. Preferred Requirements Bachelor's Degree preferred. Expertise: Qualifications -Education/Experience/Training/Etc Required: Bachelor's degree in Biochemistry, Biology, Microbiology, Chemistry or related scientific field is strongly preferred. 01-02 years related experience required. Regular and predictable on-site attendance Ability to work non-standard schedule as needed While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. Responsibilities: Other Duties: The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons. Physical Demands: While performing the duties of this job, the employee is expected to: Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Lifting, Carrying, Pushing, Pulling and Reaching: Occasionally:Push/pull, Sit Frequently:Reaching upward and downward, Stand, Visual Acuity with or without corrective lenses Constantly:N/A Activities: Occasionally:Push/pull, Sitting , Stooping/squatting, Talking - ordinary, loud/quick Frequently:Finger feeling, Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking Constantly:N/A Environmental Conditions: Occasionally:Proximity to moving parts, Fumes Frequently:N/A Constantly:N/A Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Noise Intensity:Moderate Occasionally:Production/manufacturing environment Frequently:N/A Constantly:Lab environment $24.21- $29.06 The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate. B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at . Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here . All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Compensation details: 24.21-29.06 Hourly Wage PI0b3ba33495f7-1170