Job Details

  • Title: Compliance Specialist
  • Code: RCI-BMS-27197-1
  • Location: New Brunswick New Jersey (NJ) 08903
  • Posted Date: 05/15/2019
  • Duration: 6 Months
  • Status: Open
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  Job Description

  • The candidate will focus on providing quality assurance and regulatory compliance oversight across the end-to-end product lifecycle for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, with specialization in providing QA oversight for the management of electronic records and/or electronic signatures in compliance with world-wide health authority regulations, guidance documents, applicable industry accepted standards and company requirements.
  • Candidate will be reviewing computerized systems validation.
  • Strong Validation Experience needed.
  • Experience & Training in FDA GMP, GLP and GXP regulations including equipment, process cleaning and CSV.
  • Preferred CQA/CQE.
  • Excellent Technical writing skills and knowledge of MS Word, Excel & Project