Aseptic Manufacturing Specialist

hace 2 días


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

Our company, Qrc Group Llc, is committed to excellence in aseptic manufacturing and regulatory compliance. We seek a highly skilled Aseptic Manufacturing Specialist to join our team.

The successful candidate will be responsible for:

  • Ensuring compliance with FDA regulations and global standards for aseptic manufacturing processes.
  • Preparing and reviewing regulatory submissions to the FDA, including documentation and timelines.
  • Collaborating with cross-functional teams to assess and advise on regulatory aspects of facility design.
  • Staying current with FDA regulations and industry standards for aseptic processing and pharmaceutical products.
  • Supporting the development and implementation of CAPA plans and responses to regulatory authorities.

Qualifications for this role include:

  • Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred).
  • Minimum 5 years of regulatory experience in the pharmaceutical or biotechnology industry, focusing on aseptic manufacturing and FDA submissions.
  • Strong knowledge of FDA regulations and aseptic processing guidelines.
  • Experience with FDA inspections and audits.


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