Laboratory Operations Supervisor

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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 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 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 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 Bio Life 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).…