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Regulatory Affairs Assistant / QC

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Beutlich, LLCBunnell, FL
  • Company founded in 1954 is seeking an addition to the Regulatory team for a position requiring exceptional attention to detail and proofreading skills with particular focus on understanding specifications and regulatory requirements.
  • This Regulatory Affairs-QA position is responsible for the inspection and disposition of all incoming product - including returned items, literature, and marketing materials.
  • Accuracy and precision in all tasks is essential.
  • All production documentation review including CofA, CofC, CofM.
  • Accurate and complete record-keeping for received product.
  • Submitting requests to FDA for export certificates and pharmaceutical product.
  • Formal document/procedure changes.
  • Provide training to key staff as procedures are approved.
  • CAPA documentation, trending, reporting to management, summary and closure.
  • Maintaining Registration status for Company products - establishment licenses, listing, UDI, GMDN, etc.
  • Perform internal audits according to defined schedule with full documentation
  • Provide all requested information and documentation during external audits or when requested from management.
  • Work closely with other departments to optimize processes and maintain the overall quality system.
  • Computer skills to create and format documents using Microsoft Office products is required.
  • Occasional lifting or moving of boxes up to 30 pounds.
  • The Regulatory Affairs-QA position requires a high level of professional acumen, strong decision-making skills, diligence, and the ability to manage multiple complex projects.
  • Familiarity with government requirements (FDA, ISO, Health Canada, etc.)
  • A college degree in natural science (Chemistry, Biology, etc.)
  • and/or Quality Control/Quality Assurance (auditing/inspections) experience is highly preferred.
  • Company offers paid vacation and holidays, sick leave, healthcare (medical, dental, vision), 401k, and a competitive salary contingent on experience.
  • Drug Screening with background and reference checks will be required prior to employment.
  • Job Type: Full-time
  • Quality Assurance: 1 year
  • Quality Control: 1 year
  • Auditing: 1 year
  • Please review all application instructions before applying to Beutlich, LLC.
  • About this company

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