• QA
  • Durham, NC, USA
  • Full Time

Essential Responsibilities:

  • Able to perform Quality Assurance (QA) audits, inspections (internal/external) and monitoring procedures against standard operating procedures, methods, protocols/plans, guidances, and/or regulations, as applicable
  • Issue QA statements for reports as needed
  • Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required
  • Assist in writing and reviewing QA standard operating procedures
  • Positively impacts the company through successful contributions, active participation and identification of compliance gaps
  • Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks
  • Assist in document management activities
  • Perform duties with minimal QA Management oversite
  • Other duties as needed

Minimum Acceptable Qualifications:


  • Bachelor's degree in biology, chemistry, biochemistry or a related field and a minimum of 3 years of experience in the field or in a related field
  • Minimum of 1 year experience working in an environment subject to FDA GLP, FDA GMP and/or FDA GCP regulations


  • Internal and/or external GxP auditing experience
  • Ability to work in fast paced environment where multiple projects are in process and must be completed in a timely manner
  • Excellent oral and written communication skills
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