QA Auditor
Raleigh Durham Area

Currently seeking a talented and dedicated QA Auditor for a great opportunity in the Raleigh Durham area.

Responsibilities of the QA Auditor

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

Requirements of the QA Auditor

  • Bachelor's degree in biology, chemistry, biochemistry, or other scientific discipline
  • Not less than two (2) years' experience working in a QC GMP laboratory
  • Not less than three (3) years' experience in GMP quality assurance (QA)
  • Experience working in biotech, pharmaceutical, CRO/CMO or similar organization
  • 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 verbal and written communication skills
  • Ability to deal effectively with a diversity of individuals at all organizational levels
  • Acute attention to detail
  • Proficiency in Microsoft Office (Word, Excel, Outlook, etc.)
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