Batch Disposition Lead Analyst

Takeda•Round Lake, IL

2d•Onsite

About The Position

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.

Requirements

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.

Responsibilities

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.