Quality Auditor II

Job Summary

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.

• 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.

• 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

• 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
• Perform good housekeeping (GHP) audits
• Perform other duties as assigned.

• Complete required training on time (includes Master Control, live company trainings, New Employee Orientation, etc.)
• Know and follow company policies and procedures.

• A.A. / A.S. and three years applicable NLI laboratory experience OR B.S. (Microbiology or biological science degree strongly preferred or NLI equivalent)
• Two years NLI applicable laboratory or quality experience in addition to demonstrated proficiency for attention to quality.
• Master trainer in job description functions.

• Attention to detail
• Proficient verbal & written communication skills
• Ability to work independently
• Independent/ collaborative decision making/problem solving
• Time management- response time, meeting deadlines
• Excellent customer service/interpersonal skills
• Ability to multi-task
• Self-motivated/initiative
• Conflict management
• Follow instructions/assist others
• Presentation skills/public speaking for dashboards
• Project presentation
• Basic Algebra/ math skills
• Basic computer skills
• Dependable

Must be able to stand and walk in the lab 60% of the day and sit and type at a computer for 40% percent of the day. Lifting is minimal.