Lab Quality Coordinator - 2nd Shift

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 Us:

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 centers and most importantly our commitment to our patients is expected. 

BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.

What Takeda can offer you:

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.

More about us:

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.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives 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.
 

Role Overview:

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 (CLIA), and applicable Takeda and BioLife policies, procedures and quality initiatives. 

Performs quality assurance activities of BioLife 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.

• Maintains familiarity with laboratory operating and quality assurance/quality control procedures and quality system processes in order to effectively perform laboratory quality assurance functions.

• Adheres to the laboratory quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.

• Identifies problems that may adversely affect test performance or reporting of test results and either correct the problems or immediately notify the laboratory management.

  • 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.

• 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.

• Other duties as assigned.