Batch Disposition Lead Analyst

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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 Takedas mission of delivering high-quality products.

• 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.

• Typically requires bachelors 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.

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 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.

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

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

Job Exempt