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Quality and Regulatory Specialist

Philadelphia Metro Area, PA

Posted: 05/21/2018 Job Type: Scientific Job Number: JN -052018-21645
  • QA Specialist
  • BS/MS in Scientific Field 1 -3 years of pharma QA
  • Drug development, NDA and Regulatory Experience
  • Responsible for system wide quality, system implementation and process improvement
  • Ensure all aspects of pharmaceutical quality assurance including component, intermediate, bulk and finished product release, equipment cleaning verification, qualifying equipment , document management, internal and external audits, regulatory relations, complaint handling, NDA submissions, cGMP training of employees, and other duties as assigned.
  • Document control through management, issuance, authoring, and approval of documents (SOPs, Monographs, Investigations)
  • Qualify and manage equipment in the QA databases
  • Responsible for the training of all employees with regards to quality and cGMP
  • Lead supplier, client and FDA audits
  • Proactive Quality by Design, not reactive auditing, root cause analysis

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