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Job Description

About the role:

The QC Lab Support Specialist supports quality and compliance processes across the QC Lab organization. You will handle tasks such as coordinating with external laboratories, overseeing inventory, managing preventive maintenance and calibration schedules for QC lab instruments, collaborating with vendors for advanced technical support, and compiling essential metrics and quality data reports. The Specialist conducts lab investigations, helps resolve deviations, and implements Corrective and Preventive Actions (CAPAs) to mitigate risks and enhance practices. Being a QC lab gatekeeper, you will evaluate compliance gaps, leads SOP revisions and reviews, and drives process improvements, promoting a culture of continuous improvement and quality excellence in QC operations.

How you will contribute:

• Support daily operations by coordinating activities, troubleshooting, and coordination to enhance department metrics.
• Promptly address and resolve issues in Lab Support team-managed processes.
• Facilitate external lab testing processes to support product release timelines.
• Organize preventive maintenance for QC lab instruments and coordinate with vendors.
• Manage equipment and reagent/inventory controls.
• Be a primary contact for QC CAPAs, gap assessments, and overseeing reviews of SOPs.
• Write and review SOPs and documents to ensure compliance with regulatory policies.
• Help prepare and maintain annual quality reports (Product Quality Review (PQR), Yearly Biologic Product Report (YBPR)) and reviews.
• Help investigate sample discrepancies and product deviations.
• Conduct laboratory investigations to ensure issues are resolved.
• Support and mentor teams in problem-solving sessions to implement corrective actions.
• Collaborate in lab investigation and deviation-related meetings to support QC team members and uphold compliance standards.
• Support audits by maintaining records and preparing reports for closing observations.
• Help represent the department during product releases and compliance audits.
• Contribute to Lean or Six Sigma projects, applying tools like DMAIC and 5S to enhance processes.
• Ensure data integrity and compliance with company and regulatory standards.
• Support and deliver specialized training programs to promote adherence to CGMPs and EHS regulations, emphasizing process improvement initiatives.
• Participate in regulatory and non-regulatory audits, ensuring readiness and compliance excellence.
• Perform additional duties as assigned to meet team objectives.

What you bring to Takeda:

• Bachelor's degree in chemistry or Biological Sciences with minimum 1 year of related experience in quality operations and/or equivalent years in biotechnology, pharmaceutical or similar GMP manufacturing environment.
• Knowledge of Current Good Manufacturing Process (cGMP)and Good Document Practices (GDPs).
• Knowledge of QC lab processes such as analytical lab processes, environmental monitoring, testing methods/assays and stability.
• Knowledge in Quality Systems (lab investigation and deviation management, change control, document control) and regulatory guidelines.
• Knowledge in investigations (including strategies), root cause analysis, and comprehensive reporting.
• Knowledge in computer systems (e.g., Trackwise, Veeva, Labware, MODA, JDE, ARIBA, SAP, MS Office applications).
• Analytical skills for interpreting scientific, statistical data, and along with experience using statistical tools.
• Experience working in teams and contributing to group goals.
• Focused on details to ensure accurate and quality work.
• Motivated, flexible, and eager to learn in a team environment.
• Able to work independently with some guidance and contribute to team project.

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• The position primarily involves sedentary work.
• Able to perform gowning operations (donning over garments and head covers).
• Occasional balancing and standing required during gowning and while inside clean rooms.
• Special gowning required for controlled or clean room environments.
• Laboratory environment with inside working conditions, possibly requiring entry into hot, cold, or wet production areas.
• May be required to manage hazardous waste in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
• May work around Methotrexate, which is a known cell growth inhibitor.
• Immunization may be needed for work in manufacturing areas.
• Flexibility in working hours and shifts is expected to meet production and validation objectives, including weekends and holidays.

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 deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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U.S. Base Salary Range:

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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