Senior QA Auditor
Raleigh Durham Area

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

Responsibilities of the Senior QA Auditor

  • Leads and performs quality assurance (QA) audits, inspections (internal and external), and monitoring procedures against standard operating procedures, methods, protocols/plans, guidances, and/or regulations with supervision, as applicable
  • Issues QA statements for reports, as needed
  • Assists in writing and reviewing QA standard operating procedures.
  • Assists QA management in training new QA staff
  • Reviews and assists in closing deviations, investigations, corrective actions, and preventive actions plans
  • Assists in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required
  • Obtains and maintains professional and technical knowledge by attending educational workshops; reviewprofessional publications; establish personal networks
  • Positively impacts the company through successful contributions, active participation and identification of compliance gaps
  • Assists in document management activities
  • Performs duties without QA Management oversite
  • Other duties as needed

Requirements of the Senior QA Auditor

  • Bachelor's degree in biology, chemistry, biochemistry, or other related scientific discipline
  • Not less than two (2) years' experience working in a laboratory/bench role
  • Not less than five (5) years' experience in GLP/GCLP quality assurance (QA)
  • Not less than seven (7) years' experience working in biotech, pharmaceutical, CRO/CMO or similar organization
  • Experience with analysis of laboratory data and processes, including but not limited to: data from assays and sample analysis
  • Knowledge and understanding of laboratory operations, including but not limited to: performing assays, following SOPs, and reviewing data in line with protocols
  • Knowledge of GxP, GLP, FDA, and other regulatory agency guidelines
  • Demonstrated ability to perform GxP audits based on SOPs and applicable FDA regulations, ICH guidelines, and to all other standards or guidelines
  • Demonstrated ability to independently review study documents for compliance with regulatory requirements or BioAgilytix procedures
  • Excellent oral and written communication skills
  • Proficiency with Microsoft applications (i.e., Word, Excel, and Outlook)
  • Versatility, flexibility, and willingness to work within constantly changing priorities
  • Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
  • Ability to deal effectively and respectfully with diverse individuals at all organizational levels
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