Quality Coordinator - 2nd Shift

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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 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 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 (CUA), and applicable Takeda and Bio Life policies, procedures and quality initiatives.

Performs Quality Assurance activities at the Bio Life 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. (70%)
• Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system processes in order to effectively perform laboratory quality assurance functions. (5%)
• Adheres to the laboratory quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. (5%)
• Identifies problems that may adversely affect test performance or 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 review and or validation of SOPs as needed. (5%)
• 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. (5%)
• Other duties as assigned.

DIMENSIONS AND ASPECTS:

Technical and 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…