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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.