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Quality Assurance Associate II

NJ, NJ
PharmEng Technology is currently seeking a Quality Assurance Associate in New Jersey. The position is available immediately conditional of a successful interview.

Job Description:
  • Responsible for ensuring compliance with GVP, regulations and established procedures.
  • Support the review of PV data (ICSRs, PSRs etc.)  
  • Utilize Quality Assurance databases and review documentation for compliance with GVP, FDA, ICH and other regulatory requirements and perform administrative tasks.

Job Requirements:  
  • B.Sc. degree in life sciences or related field and a minimum of 5 years of experience within the Biopharmaceutical Industry.
  • Previous case processing experience required.
  • Quality management experience required.
  • International regulations knowledge required (ICH, CIOMS, EMEA and FDA).
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