Lead Specialist, Sterilization And Microbiology - Exton, Pa

Firmenich

Exton, PA, United States
Base: $66,000.00 - $90,000.00; bonus/equity: annua...
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Bachelor's degree in biological science
3-5 years qa/qc experience
Sterilization experience gamma ebeam eto
** The Lead Specialist, Sterilization and Microbiology position at Firmenich in Exton, PA, is responsible for overseeing sterilization activities, managing contamination control policies, and ensuring compliance with quality standards in the medical device and pharmaceutical industry. The ideal candidate will have a background in biological sciences, experience in quality assurance/control, and familiarity with sterilization methods and environmental monitoring. **

Job Summary

  • The Lead Specialist will support sterilization activities and manage contamination control policies for Biomedical manufactured products.
  • This role serves as a technical liaison for laboratory functions and oversees the Environmental Monitoring Program to ensure patient safety.
  • Candidates must possess strong knowledge of cGMP, ISO, USP, and AAMI standards within a highly regulated quality environment.

Matching Summary

Match Score: 75

** The Lead Specialist, Sterilization and Microbiology position at Firmenich in Exton, PA, is responsible for overseeing sterilization activities, managing contamination control policies, and ensuring compliance with quality standards in the medical device and pharmaceutical industry. The ideal candidate will have a background in biological sciences, experience in quality assurance/control, and familiarity with sterilization methods and environmental monitoring. **

Salary

Base: $66,000.00 - $90,000.00; Bonus/Equity: Annual incentive pay included; Benefits: Comprehensive health, retirement savings, paid time off

Skills & Requirements

Must-have

  • Bachelor's degree in Biological science
  • 3-5 years QA/QC experience
  • Sterilization experience gamma Ebeam EtO
  • Knowledge of ISO 13485 standards
  • Understanding of FDA Regulations 21CFR820

Nice-to-have

  • Environmental monitoring experience
  • Clean room experience
  • MDD certification knowledge
  • Statistical knowledge for Quality Assurance

Key Requirements

  • Bachelor's degree in Biological science
  • 3-5 years experience in QA/QC
  • Required sterilization experience (gamma, Ebeam, EtO)

Work Rights

Not specified

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