Quality Associate Ii – Qa Ops

Takeda

Round Lake, IL, USA
Base: $71,800.00 - $112,860.00; bonus/equity: shor...
2 day onsite (tuesday-saturday, 3:00 pm – 11:30 pm)
Bachelor's degree in science or engineering
2+ years related work experience
Knowledge of fda regulations and gmp
Takeda is seeking a Quality Associate II for their pharmaceutical manufacturing facility in Round Lake, IL. The role focuses on ensuring product quality and compliance through documentation review, investigations, and quality oversight, primarily on the second shift from Tuesday to Saturday

Job Summary

  • This role focuses on driving the Quality on the Shop Floor program by managing SOPs, analyzing quality observations, and preparing reports for leadership.
  • The position requires strict adherence to FDA regulations and Good Manufacturing Practices while overseeing raw material release, batch records, and change controls.
  • Takeda offers a competitive salary range of $71,800 to $112,860 along with comprehensive benefits including medical insurance, 401(k) matching, and paid time off.

Matching Summary

Match Score: 85

Takeda is seeking a Quality Associate II for their pharmaceutical manufacturing facility in Round Lake, IL. The role focuses on ensuring product quality and compliance through documentation review, investigations, and quality oversight, primarily on the second shift from Tuesday to Saturday.

Salary

Base: $71,800.00 - $112,860.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k), paid vacation, sick time, tuition reimbursement

Skills & Requirements

Must-have

  • Bachelor's degree in science or engineering
  • 2+ years related work experience
  • Knowledge of FDA regulations and GMP
  • Experience with aseptic filling processes
  • Proficiency with TrackWise and JDEdwards systems
  • Ability to work swing shift 3pm-11:30pm
  • Must not be allergic to Cephalosporin drugs

Nice-to-have

  • Strong leadership and cross-functional collaboration skills
  • Excellent problem-solving and critical thinking abilities
  • Experience leading quality project teams
  • Ability to travel up to 25% for training
  • Strong verbal and written communication skills

Key Requirements

  • Bachelor's degree preferred in science or engineering
  • Minimum 2 years of related work experience
  • Knowledge of aseptic filling and packaging processes
  • Must not have Cephalosporin drug allergies

Work Rights

Not specified

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