Validation Associate II

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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 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 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  

BioLife Laboratory Validation Associate is responsible for the management and execution of project and system qualifications, validations, re-qualifications, and revalidations of laboratory facilities, equipment, utilities, and processes.  Ensures compliance with regulations and proper documentation 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. Position may focus on equipment, process, or control systems validation.

ACCOUNTABILITIES

• The development and completion of documentation on protocols, including test cases and final reports.
• Manage documents and follow up on validation projects, including new equipment selection, acquisition, installation, and use, facility/system/process improvements, modifications, and additions, and computer-based systems and software. 
• Organizes and performs the logging and archiving of validation documents. 
• Assist in the creation of validation protocols and requalification programs.
• Coordinate/perform the test activities necessary to execute the validations.
• Review/summarize the results and conclusions of the validations.
• Coordinate any software control activities used in the manufacture, testing, approval, or documentation of the product.
• Performing technical failure analysis on processes/products not meeting specifications.
• Developing statistical process control programs to monitor processes.
• Reporting on trends to reduce product/process variability.
• Apply statistical analysis and design of experimental approaches to process development activities.
• Works on moderate to complex problems where analysis of situations or data requires an in-depth evaluation of various factors or intangible variables.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• May determine method