Batch Disposition Lead Analyst

Takeda

Round Lake, IL, USA
Base: $89,900.00 - $141,240.00; bonus/equity: elig...
Onsite
Bachelor's degree in science or engineering
4+ years of quality disposition experience
Knowledge of fda regulations and gmp
This role ensures the quality of processes and product outputs by defining activities and standards to meet regulatory requirements

Job Summary

  • This role ensures the quality of processes and product outputs by defining activities and standards to meet regulatory requirements.
  • The successful candidate will lead cross-functional teams in risk management, approve investigations and CAPAs, and represent the organization to governmental bodies.
  • Takeda offers competitive compensation including medical, dental, vision insurance, a 401(k) plan, and up to 80 hours of sick time annually.

Matching Summary

This role ensures the quality of processes and product outputs by defining activities and standards to meet regulatory requirements.

Salary

Base: $89,900.00 - $141,240.00; Bonus/Equity: Eligible for short-term and/or long-term incentives; Benefits: Medical, dental, vision, 401(k), paid vacation, and sick time

Skills & Requirements

Must-have

  • Bachelor's degree in science or engineering
  • 4+ years of quality disposition experience
  • Knowledge of FDA regulations and GMP
  • Ability to work flexible hours and rotations
  • Experience with validation documentation and CAPAs

Nice-to-have

  • Strong cross-functional collaboration skills
  • Excellent problem-solving and critical thinking
  • Experience presenting to plant management
  • Ability to thrive in a fast-paced environment

Key Requirements

  • Bachelor's degree preferred in science or engineering
  • Minimum 4 years of related work experience
  • Must be willing to work nights, weekends, and holidays
  • No allergies to cephalosporin required for manufacturing environment

Work Rights

Not specified

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