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Job Description

About the role:

The primary responsibility is to ensure compliance with procedures and regulatory requirements in the manufacturing facility. You are responsible for quality support and oversight of manufacturing operations, which includes presence on the floor and for performing Acceptable Quality Limit (AQL) sampling of finished product. Additional responsibilities include assessment for potential issues on the floor, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, sample management, kitting of batches, and raw materials release.

How you will contribute:

• Perform Acceptable Quality Limit (AQL) sampling of finished product. Identify and assess quality risk in production operations daily.
• Build Total Integrated Quality (TIQ)/ Quality on the Shop Floor (QOTSF) and review of checklists. Programs are part of manufacturing support and compliance enforcement.
• Initiate JDE (inventory management system and preventive maintenance system) work orders if required to address issues in.
• Perform sample management (Sterility, stability) to appropriate facilities and responsible for appropriate storage and disposal of retention samples. Samples Raw Materials in an ISO Classified environment, including preparation and shipment of samples to the required laboratories.
• Initiate investigations in the event of a failure about processes or Raw Material that is deemed to be out of specification.
• Perform assessment with manufacturing, engineering, and maintenance to resolve potential issues on the floor and escalate.
• Facilitate kitting operations for packaging – issue and return of preprinted materials physically and electronically.
• Handle movement of materials/products physically and electronically for quarantine and reject areas.
• Review Lead Manufacturing support activities including batch record documentation review. Perform approval of batch documentation and consult with manufacturing to address any required corrections.
• Subject Matter Expert (SME) and provides training to other employees.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.
• Monitor product quality through the performance of required visual testing follow ups.
• Contribute to a team setting within quality operations and potentially with other work teams to increase efficiency, produce cost savings, improve quality, and provide new product support.
• Support regulatory audits.

What you bring to Takeda:

• High School Diploma or GED with 2+ years of related work experience or Associates degree or higher and 1+ years related work experience.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Work with JDE, EBM, TW workflows, Systech and other Learning Management and Document Management systems.

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. You may:

• In general, your work will be a combination of sedentary work and walking around observing conditions of the facility.
• Can carry up to 10lbs, lift up to 10lbs, push/pull up to 20lbs (with assistance of material handling equipment).
• Will stand and walk for an extended period over an 8–12-hour shift between rooms and across the site.
• May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks
• Repetitive motion