QA Auditor I/II

At BioAgilytix, we are passionate about premier science and the impact it has on our world. We are seeking a Quality Assurance Auditor at our Durham, NC laboratory.

Requirements

• Performs Quality Assurance (QA) audits, inspections (in-phase as needed), and reviewing procedures against standard operating procedures, methods, protocols/plans, guidance documents, and/or regulations, as applicable
• Reviewing assay data (including equations, calculations, audit trails, etc.) and verifying reportable results on certificate(s) of analysis
• Reviewing laboratory investigations, out-of-specifications/expectations, deviations, and CAPAs, if applicable
• Reviewing assay qualification and validation reports
• Issue QA statements for reports as applicable
• 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 oversight

Benefits

• Company paid medical and dental insurance
• 401(k) matching
• Generous Paid Time Off