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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 external CMOs in all areas of quality and internal quality related activities. The successful candidate will:

  • Review and approve quality documentation from CMOs, including change controls, deviations, annual product reviews, and complaint investigations.
  • Review batch records and perform batch release related activities.
  • Monitor stability data.
  • Log and process product inquires, product quality related complaints and pharmacovigilance activities.
  • Assist in ensuring that all commercial products adhere 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 2 to 3 years work experience in US FDA regulated pharmaceutical development and manufacturing.
  • Experience with 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 careers4@edenbridgepharma.com.