Quality APR Coordinator

3 weeks ago


Johnson City, United States Crown Laboratories, Inc. Full time
Job DescriptionJob DescriptionPosition Summary

Quality Assurance coordinator is responsible for preparation of Annual Product Reviews for all manufactured products and organizing and tracking all retain samples obtained from manufactured batches.

Main Accountabilities

  • Prepare Annual Product Review reports for all products manufactured and trending data
  • Responsible for organizing and tracking all retain samples obtained from manufactured batches.
  • Assist in developing procedures to ensure regulatory compliance
  • Familiar with standard concepts, practices, and procedures of FDA
  • Relies on experience and judgment to plan and accomplish goals.

Additional Accountabilities

  • May also cross train in other Quality Systems areas such as CMO Vendor Management, QA Vendor Qualifications and Approvals, Document Control, Customer Complaints.

Qualification/Skills
  • Associates degree (minimum) in a scientific discipline is preferred; Experience in Pharmaceutical Quality Assurance or Regulatory Affairs in lieu of degree will be considered.
  • Minimum of 1-3 years progressive experience within Pharmaceutical Quality Assurance or Regulatory Affairs
  • Minimum 1 year hands on preparation and compilation of Annual Product Reviews preferred.
  • Some understanding of FDA and ICH regulatory guidelines, processes and best practice.
  • Experience with Cross-functional teams
  • High attention to detail, tenacity and diplomacy.
  • Excellent interpersonal, communication (written and verbal), organizational skills and computer skills, including Microsoft Office Suite.
  • Demonstrated ability to operate with a considerable degree of initiative and independence (ie, a thinking writer).
  • Proven ability to work in a focused environment, often to tight timelines.


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