The Quality Auditor II reviews GLP studies for completeness, compliance, concurrence, and accuracy. The auditor provides regulatory and policy and procedural guidance. The auditor collaborates with lab personnel in design, implementation, and performance of testing with the goal of improving and building quality into the process. The auditor demonstrates proficient knowledge of quality practices and can perform job functions extending throughout the auditor's quality audit team. Additionally, the auditor demonstrates proficiency in independent decision-making in regards to the interpretation of standards and regulations, performance of investigations, and other quality practices. The auditor has a history of successful process improvement implementation.
Experience:
Working experience performing Quality Audits in a Laboratory setting or similar
Background working with functional teams to identify deviations and design solutions
Education:
Bachelor Degree in a relevant Life Science Preferred (Microbiology, Biology, Chemistry, etc..)
2+ years working experience as listed above strongly preferred
5+ years experience preferred in the absence of a completed Bachelors
Essential job functions:
GLP Studies
Review each GLP study prior to release for testing.
Audit a portion of each GLP study.
Review each GLP study and final report prior to mailing.
Regulatory and Policy & Procedural Guidance
Know and follow GLP, GMP and relevant ISO regulations
Perform quality event investigations and approvals
Trend quality events
Review and approve protocol detail sheets
Review out of range forms
Review discontinued studies
Review and trend amended reports
Review duplicate reports
CAPA: Initiation, investigation, resolution, and verification
Review documents in Master Control (collaboration and approval)
Review logbooks
Process Improvement
Meet regularly with Section Leader, Study Directors and Lab Analysts
Prepare Dashboard and Quarterly Management Review with Section Leader
Audit studies in-process
Assist Regulatory Affairs with internal audits
Review and approve equipment qualifications and test method validations
