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Quality Assurance, Associate

Job Description

Edenbridge Pharmaceuticals is seeking a Quality Assurance Associate to join the Company at its Parsippany, NJ corporate office. The position will be responsible for working with internal resources and third party CMOs in all areas of quality and pharmacovigilance related activities. The successful candidate will:

  • Review and approve quality related documents including change controls, deviations, annual product reviews, and complaint investigations.
  • Review batch records and perform batch release related activities.
  • Monitor and analyze stability data.
  • Receive, respond to and process product inquires and quality complaints, and oversee all Company pharmacovigilance activities.
  • Oversee commercial product adherence to the requirements of the Drug Supply Chain Security Act.
  • Maintain internal quality systems such as training and procedure updates.
  • Qualifications

  • Bachelor's degree with 3+ years work experience in US FDA regulated pharmaceutical development and manufacturing.
  • Experience with pharmaceutical manufacturing facilities and quality systems.
  • Excellent organizational and time management skills, as well as communication and interpersonal skills across all levels of the Company.
  • Self-starter who can be effective with minimal supervision.
  • Previous experience working in a small-to-midsize company environment.
  • Excellent writing skills consistent with the ability to prepare concise, timely and accurate reports.

Qualified candidates should submit their resumes directly to careers6@edenbridgepharma.com.