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Job Description

About the role

As a Quality Assurance Specialist I, you will manage Deviations (Events) and Corrective and Preventive Actions (CAPAs) within Takeda's Quality Systems program. It involves collaborating with plasma suppliers to ensure ongoing communication and to monitor the resolution of identified discrepancies. Furthermore, we are looking for the tracking and trending of relevant data, as well as the preparation and presentation of monthly and quarterly metrics in alignment with established Key Performance Indicators (KPIs). You will report to Supervisor Quality Systems.

This is currently a hybrid role, requiring in-office presence three days a week.

How you will contribute

• Manage and resolve internal/external deviations and CAPAs in Takeda's Quality Systems for plasma, operations, supply chain, and suppliers.
• Document, investigate, and ensure closure of discrepancies using the PQR Quality System.
• Conduct process audits and maintain regulatory and SOP compliance; improve initiatives.
• Oversee Quality vault management, ensuring proper check-in/out, filing, and retention of records per SOPs.
• Review, and revise department-owned procedures and documents in Veeva to ensure compliance.
• Perform quality reviews/dispositions of plasma lots and shipments, including managing holds or releases in APDS and ensuring destruction of unsuitable units.
• Execute Lookback activities and document PDI notifications from plasma suppliers within set timelines.
• Lead continuous improvement projects and internal/external audits, supporting closure of observations.
• Prepare and deliver process performance updates and metrics to stakeholders and management.
• Communicate with quality, manufacturing, support groups, and suppliers to ensure plasma availability and resolve discrepancies; maintain forklift certification

What you bring to Takeda:

• BA / BS degree in Life Sciences and/or Business required or equivalent experience.
• Proficient/Intermediate knowledge of MS Office (Word, Excel, Visio, and PowerPoint).
• Minimum 2 years of experience in the Plasma / Whole Blood Industry or Biopharmaceutical / Biotech would be ideal.
• Minimum 2 years of experience in a quality organization would be ideal.
• Maintaining certification on Powered Industrial Truck use (Forklift) is highly desirable. 
• Knowledge in computerized systems (e.g., APDS, TrackWise, C3ME, or other inventory management or quality systems software would be ideal.
• Possess in-depth knowledge of regulatory, quality, and FDA requirements (cGMP, GDP) relevant to Biologics.
• Write clearly, present effectively, and convey technical information to diverse audiences.
• Exhibit organizational, analytical, and problem-solving abilities.
• Proficient in Qlik, and Power BI for data management and reporting tasks.
• Lead, motivate, and train team members, acting as a catalyst for change and continuous improvement.
• Collaborate diplomatically across functions, with suppliers, and support audit readiness and process compliance.
• Identify process gaps, recommend solutions, and communicate issues and actions to management.

Important Considerations

• Must be able to lift, push, pull, and carry up to 50 lbs.
• The position requires a combination of sedentary work and walking around observing conditions in the facility.
• Must be able to work in cold temperature conditions ranging from -28°C-+8°C
• Must be able to wear special personal protective equipment required in cold environments over the head, face, hands,