Associate Specialist, Quality Assurance

leHACK

Base: $71,900.00 - $113,200.00; bonus/equity: annu...
Hybrid
Bachelor's degree in sciences
Two years quality experience regulated industry
Knowledge of cgmp and usda regulations
This role serves as the Quality Integrated Process Team Representative for Fermentation, Downstream, and Single Use Bioreactors manufacturing areas within a company pioneering groundbreaking science for over 130 years

Job Summary

  • This role serves as the Quality Integrated Process Team Representative for Fermentation, Downstream, and Single Use Bioreactors manufacturing areas within a company pioneering groundbreaking science for over 130 years.
  • Primary responsibilities include reviewing and approving batch records, managing deviations and CAPAs, conducting change controls, and ensuring inspection readiness across the site.
  • The successful candidate will navigate perspectives of Planning, QA, and Production while holding Safety and Quality as primary values in a hybrid work model requiring three days on-site per week.

Matching Summary

This role serves as the Quality Integrated Process Team Representative for Fermentation, Downstream, and Single Use Bioreactors manufacturing areas within a company pioneering groundbreaking science for over 130 years.

Salary

Base: $71,900.00 - $113,200.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • Bachelor's degree in sciences
  • Two years quality experience regulated industry
  • Knowledge of cGMP and USDA regulations
  • Experience with investigations and risk assessment
  • Strong technical writing skills

Nice-to-have

  • Familiarity with vaccine manufacturing processes
  • Strong Microbiology background
  • Project Management experience
  • Experience with SAP or Reliance systems
  • USDA regulatory inspection experience

Key Requirements

  • Associate's Degree with 5 years relevant experience OR Bachelor's Degree
  • Minimum two years of Quality experience in regulated industry
  • Degree in sciences preferred
  • No visa sponsorship available

Work Rights

Not specified

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