Quality Associate Ii – Qa Ops

Takeda

Round Lake, IL, United States
Base: $71,800.00 - $112,860.00; bonus/equity: shor...
Raw material documentation review
Batch record review
Quality oversight of manufacturing
As a Quality Associate II, you will perform review and approval of released raw material documentation, focusing on product quality and compliance through documentation review, investigation/change control approvals, and quality oversight of manufacturing processes

Job Summary

  • As a Quality Associate II, you will perform review and approval of released raw material documentation, focusing on product quality and compliance through documentation review, investigation/change control approvals, and quality oversight of manufacturing processes.
  • This role is responsible for driving the Quality on the Shop Floor (QOTSF) program, including owning, managing, and approving SOPs, trending quality observations, and preparing reports for leadership.
  • U.S. Base Salary Range: $71,800.00 - $112,860.00; 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, among others.

Matching Summary

As a Quality Associate II, you will perform review and approval of released raw material documentation, focusing on product quality and compliance through documentation review, investigation/change control approvals, and quality oversight of manufacturing processes.

Salary

Base: $71,800.00 - $112,860.00; Bonus/Equity: short-term and/or long-term incentives; Benefits: medical, dental, vision insurance, 401(k) plan and company match, among others

Skills & Requirements

Must-have

  • Raw material documentation review
  • Batch record review
  • Quality oversight of manufacturing
  • Aseptic filling knowledge
  • FDA Regulations knowledge
  • Good Manufacturing Practice application

Nice-to-have

  • Strong leadership influence
  • Cross-functional collaboration
  • Thrive in fast-paced environment
  • Attention to detail
  • Problem-solving skills
  • Critical thinking skills

Key Requirements

  • Bachelor's degree in science, engineering, or related technical field
  • 2+ years of related work experience
  • Knowledge of aseptic filling, visual inspection, and packaging manufacturing processes
  • Knowledge of FDA Regulations and Application of Good Manufacturing Practice
  • Ability to work on multiple shifts, including weekends
  • Ability to lift, push, pull and carry up to 50 lbs

Work Rights

Not specified

Tailored Resume

Cover Letter