Quality Assurance Specialist

3 weeks ago


Totowa, New Jersey, United States Englewood Lab Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Englewood Lab. In this role, you will be responsible for conducting annual drug and device history reviews, maintaining regulatory compliance documents, and participating in internal and external audit processes.

Key Responsibilities
  • Conducts annual drug and device history reviews to ensure compliance with regulatory requirements.
  • Maintains regulatory compliance documents, including records retention and document control.
  • Participates in internal and external audits to ensure quality standards are met.
  • Maintains SOPs and quality forms as part of document control.
  • Tracks and performs physical sample retention review for annual drug reviews and device history reviews.
  • Tracks, maintains, and closes requests for change control notices, defective material forms, and deviations.
Requirements

To be successful in this role, you will need:

  • A minimum of 2 years of diploma program or 4-year college degree.
  • 2 to 3 years industry or related experience.
  • Previous experience in pharma, cosmetics, food, medical device, or allied profession.
  • Good technical writing ability.
  • Excellent knowledge of Word, Excel, Access, and other Windows-based programs.
  • Good record-keeping skills.
Benefits

We offer:

  • Medical, dental, and vision insurance.
  • Life insurance.
  • 401k match.

The estimated salary for this role is $65,000 - $80,000 per year, based on the location and industry standards.



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