• 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
  • Assist in regulatory training of company staff Positively impact 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 with minimum of 3 years of experience in the field
  • One to three years' experience in pharmaceutical or CRO Quality Assurance department adhering to GLP regulations and/or GCLP principles



  • 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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