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Job Description

About the role:

The primary responsibility is to serve the operations support group by ensuring compliance with procedures and regulatory requirements on the floor. You are responsible for investigations and escalation on the floor promptly to continue uninterrupted production. You are responsible for sample management (sterility, stability, etc.) and preparing shipments of those samples. Additional responsibilities include and are not limited to Triage, Deviation/CAPA initiation and investigation, raw material investigations, QOTSF, online batch documentation review, and serve as an SME for processes.

How you will contribute:

• Responsible for sample management (Sterility, stability, etc.) to appropriate facilities and responsible for the appropriate storage and disposal of retention samples.

• Complete investigations in the event of a failure on processes or Raw Material that is deemed to be out of specification.

• Triage potential issues on the floor. Initiate deviation and complete investigation.

• Revise documents to procedures, forms, and specifications.

• Manage the appropriate storage and disposal of retention and reserve samples.

• Identify and assess quality risk in production operations daily. QOTSF review of checklists and trending of observations for monthly quality council. QOTSF program management and JDE work order initiation.

• Perform Returned Goods, Product Hold, and Tagging and Untagging of non-conforming material promptly.

• Responsible for movement of materials/products physically and electronically for quarantine/reject areas and trained on PIT/forklift to move materials.

• Review and release pre-printed materials to manufacturing following cGMP procedures.

• Collect and submit rinse and bioburden samples to a laboratory.

• Oversee Manufacturing support activities, including batch record documentation review, approval of OSI PI Reports, scanner card management, label copy control and issuance, raw material release, in-process work order release, and retention sample management.

• Ensure pre-printed material label cage is maintained in a GMP state while following all EHS and 5S guidelines.

• Operate and maintain quality operations equipment. Ensure that equipment maintenance is documented promptly.

• Support execution of conformance protocols with appropriate training

• Be the Subject Matter Expert (SME) and provide training to other members.

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations.

• Monitor product quality through the performance of required visual and functional testing.

• Contribute to a team setting within the quality operations and potentially with other work teams to increase efficiency, solve problems, produce cost savings, improve quality, and provide new product support

• Support regulatory audits.

What you bring to Takeda:

• High School Diploma or GED with 4+ years of related work experience or an Associates degree or higher and 2+ years related work experience.

• Good problem-solving skills.

• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

• Proficient in Microsoft Word, Excel, Outlook, and SharePoint.

• Work with JDE, EBM, TW workflows, Systech, and other LMS/DMS.

• Experience in pharmaceutical manufacturing of sterile drug and/or biologic solutions, preferred

• Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, and application of cGMP/GDPs would be ideal

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 add