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Job Description

About the role:

The QA Specialist II is responsible for overseeing day-to-day activities within Quality Assurance Operations. This role works as part of cross-functional teams, providing quality leadership and ensuring product quality and compliance. Key responsibilities include Quality on the Shop Floor (QOTSF), Acceptable Quality Limit (AQL) inspections, incoming raw material release, documentation review (e.g., batch records and electronic batch records), and approvals for investigations and change controls. The incumbent will uphold Takeda’s Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and owning and demonstrating commitment to Quality.

How you will contribute:

• Owns and approves Standard Operating Procedures (SOPs) and other quality documentation relevant to the Quality department and all areas of the plant.

• Develops, delivers, and approves training materials related to Quality operations, ensuring alignment across all plant areas.

• Lead and manage a QA Operations team, fostering continuous development and ensuring the achievement of performance objectives. Provide leadership and oversight to quality operations and other functions and escalate if required.

• Manages investigations and CAPAs for the Quality department, providing oversight and approvals for compliance across all plant operations.

• Owns and approves change controls within the Quality department, ensuring alignment with existing compliance requirements.

• Provides Quality approval for labeling artwork and packaging material specifications using artwork management software.

• Leads Quality project teams, presenting project plans, progress, and risks to plant management, and representing the organization to regulatory bodies.

• Reviews and approves documentation following cGMP guidelines, identifying opportunities for process improvements and ensuring compliance on the manufacturing floor.

• Reviews and approves raw materials in accordance with SOPs, releasing materials for manufacturing use, resolving issues related to materials release, and overseeing preprinted material accountability, material receipt, and JDE inventory management system issues.

• Acts as a subject matter expert (SME) during internal and external regulatory audits, presenting Quality operations to auditors as needed.

• Collaborates with Manufacturing and Engineering teams through Quality on the Shop Floor (QOTSF) initiatives to drive sound, compliant Quality decisions.

• Conducts gap assessments and implements global processes to enhance Quality operations.

• Manages Final Container sampling processes as well as Quarantine and Reject processes for materials and finished products.

• Experience with visual inspection and AQL processes related to parenteral drugs is preferred.

• Knowledge of manufacturing processes related to aseptic filling, visual inspection, and packaging.

• Knowledge of FDA, EMA, CFDA, PDA Regulations, application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).

• Must demonstrate a strong ability to contribute, influence, and collaborate across functions, working effectively and efficiently in a cross-functional team environment.

• Ability to prioritize and thrive in a fast-paced environment.

• Strong interpersonal skills and attention to detail.

• Must be a team player with e