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GLP Quality Assurance Auditor
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- The Senior QA Auditor is responsible for carrying out systematic and independent examination (i.e., audit) of multiple study related activities and documents, to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, standard operating procedures (SOPs), GLP (21 CFR Part 58 and Part 11) and the applicable regulatory requirements.
- Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management.
- The Senior QA Auditor is responsible for building and maintaining effective working relationships throughout the organization and is responsible for mentoring/coaching lower-level staff.
- Autonomously performs SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications.
- Under supervision of a mentor/coach, performs the following tasks: interpretation of FDA, regulations; project management; regulatory guidance review; quality issue investigations; and QA data collection, trending and analysis.
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