Quality Assurance Specialist

1 week ago


Totowa, New Jersey, United States Englewood Lab Full time

**Job Summary**

We are seeking a highly skilled Quality Assurance Associate to join our team at Englewood Lab. As a key member of our quality team, you will play a critical role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality.

**Responsibilities:**

  • Conduct annual drug (product) reviews and device history reviews to ensure compliance with regulatory requirements.
  • Maintain regulatory compliance documents and external origin documents, as well as document control including records retention.
  • Participate in internal and external audit processes, and draft reports on such audits.
  • Maintain SOPs and quality forms as part of document control.
  • Support change control program and maintain evidence of product and process changes.
  • Maintain supplier and vendor qualification program.

**Requirements:

To be successful in this role, you will need:

  • A minimum of 2 years of diploma program or 4-year college degree.
  • 2-3 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.

**Salary and Benefits:** We offer a competitive salary range of $60,000 - $80,000 per year, depending on experience, as well as excellent benefits including medical, dental, and vision insurance, life insurance, and 401k match.



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