Senior QA Auditor
Everett, Washington On-site
$80,000–$87,000 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
As a Senior QA Auditor you will be 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. The Senior QA Auditor is responsible for reporting any findings to the Study Director or Responsible Person and Testing Facility Management. Also responsible for building and maintaining effective working relationships throughout the organization and is responsible for mentoring/coaching lower-level staff.
What you'll bring
- Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.
- 2-3 years of related technical experience and/or training.
- A minimum of two years auditing in a GLP-regulated environment.
- Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality– Certified Quality Auditor) or other certification is recommended.
- Well versed with Microsoft Office Suite
- Training needs for this position include on-the-job training in performing audits and inspections, and independent reading of professional articles, journals and internal SOPs.
- Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation, along with continual GLP training.