Batch Disposition Lead Analyst

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Job Description

About the Role:

Reporting to the Manager of Quality Disposition, the Batch Disposition Senior Analyst will work as part of a cross-functional team providing Quality oversight of the day-to-day activities related to the Quality Disposition team.

The Batch Disposition, Senior Analyst is responsible for ensuring the quality of processes and product outputs by defining activities, processes, and standards to meet quality requirements. This role involves auditing, monitoring, and determining the quality of processes or outputs against internal and regulatory standards, contributing to Takeda's mission of delivering high-quality products.

How you will contribute:

* Owns Standard Operating Procedures and other Quality Documentation relevant to area of expertise. Approves Standard Operating Procedures and other Quality Documentation pertinent to all areas of the plant.

* Audit and monitor processes and outputs to ensure compliance with internal and regulatory standards

* Develops and delivers training materials relevant to their area of expertise. Approves training materials pertinent to all areas of the plant.

* Approves validation documentation (e.g., protocols, CWRs, or risk assessments) that establishes novel requirements or assesses risk related to area of expertise.

* Leads cross-functional teams in the execution of risk management activities, when needed.

* Owns investigations and CAPAs pertinent to area of responsibility/expertise. Approves investigations and CAPAs pertinent to all areas of the plant.

* Approves change controls for compliance to existing requirements relevant to area of expertise.

* Leads Quality project teams and presents to Plant management project plans, progress, and risks independently with limited supervision.

* Represents the organization in areas of expertise to governmental Regulatory bodies.

* Coordinates daily tasks of a team of Quality Analysts

* Coach and review the work of lower-level professionals to ensure adherence to quality standards

* Act as an advisor on quality-related issues, applying judgment within defined procedures and policies

* Manage escalations related to internal stakeholders and ensure timely escalation of issues related to external stakeholders to management.

* Other duties as assigned.

What you bring to Takeda:

* Typically requires bachelor's degree, preferably in science, engineering, or other related technical field.

* 4+ years of related work experience

* Ability to work independently, collaborate cross-functionally, and utilize resources efficiently.

* Excellent Microsoft Office skills (Word, Excel, Project, and PowerPoint)

* Knowledge of disposition and release of final product.

* Ability to prioritize and thrive in a fast-paced environment

* Strong interpersonal skills and great attention to detail are necessary

* excellent problem-solving critical thinking and decision-making skills

* Must be able to handle multiple projects concurrently

* Must have knowledge of FDA Regulations and Application of Good Manufacturing Practices

* Proactively identifies, escalates, and/or resolves potential compliance and/or safety issues.

* Able to provide feedback for operations & elevate concerns as needed.

* Excellent organizational, interpersonal, verbal, and written communication skills.

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:

* Must be willing and able to work flexible hours and rotations, based on business need

* Must be able to work nights, weekends, and holidays to support manufacturing when needed

* No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment.

* May be exposed to and must not be allergic to cephalosporin.

* Ability to walk 1-3 miles and lift 10 lbs. during a workday as required.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-Onsite

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