Takeda
BatchDispositionLeadAnalyst
“Batch Disposition Lead Analyst at Takeda. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, Quality oversight, Quality Disposition, Quality Documentation, validation documentation, risk management activities, Quality project teams, Quality Analysts, quality-related issues, compliance, safety issues. Owns Standard Operating Procedures and other Quality Documentation relevant to area of expertis”
What You'll Achieve.
ensuring the quality of processes and product outputs by defining activities, processes, and standards to meet quality requirements; contributing to Takeda's mission of delivering high-quality products; ensure compliance with internal and regulatory standards; ensure adherence to quality standards
Industry & Context.
excellent problem-solving critical thinking and decision-making skills; Proactively identifies, escalates, and/or resolves potential compliance and/or safety issues
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
What They're Looking For.
Must Have
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, 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
Nice to Have
preferably in science, engineering, or other related technical field
What You'll Do.
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.
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
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
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
How You'll Work.
Team & Collaboration
work as part of a cross-functional team; Leads cross-functional teams in the execution of risk management activities; Leads Quality project teams; Coordinate daily tasks of a team of Quality Analysts; Coach and review the work of lower-level professionals; Manage escalations related to internal stakeholders; ensure timely escalation of issues related to external stakeholders to management
Communication Scope
Excellent organizational, interpersonal, verbal, and written communication skills
Process & Methodology
Leads Quality project teams, presents to Plant management project plans, progress, and risks independently with limited supervision, Must be able to handle multiple projects concurrently
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