Quality Auditor I or II
About The Position
The Quality Auditor reviews GLP studies for completeness, compliance, concurrence, and accuracy; provides regulatory and policy and procedural guidance; and collaborates with laboratory personnel on the design, implementation, and performance of testing to improve processes and build quality into them. The role requires proficient knowledge of quality practices and the ability to perform functions across the quality audit team. The auditor makes independent decisions when interpreting standards and regulations, conducting investigations, and applying other quality practices, and has a record of successful process improvement implementation. The position includes reviewing GLP studies and reports, performing and trending quality event investigations, supporting CAPA activities, reviewing controlled documents and records, and participating in process improvement and internal audit activities. The auditor also completes required training and follows company policies and procedures.
Requirements
- Attention to detail.
- Proficient verbal and written communication skills.
- Ability to work independently.
- Independent and collaborative decision-making and problem-solving skills.
- Time-management skills, including timely responses and meeting deadlines.
- Excellent customer service and interpersonal skills.
- Ability to multitask.
- Self-motivation and initiative.
- Conflict-management skills.
- Ability to follow instructions and assist others.
- Presentation skills and public speaking ability for dashboards.
- Project presentation skills.
- Basic algebra and math skills.
- Basic computer skills.
- Dependability.
- Either an A.A./A.S. degree and three years of applicable NLI laboratory experience, or a B.S. degree and two years of applicable NLI laboratory or quality experience, in addition to demonstrated proficiency in attention to quality.
- Master trainer in the job description functions.
Nice To Haves
- A B.S. in Microbiology or a biological science is strongly preferred.
Responsibilities
- Review each GLP study before release for testing.
- Audit a portion of each GLP study.
- Review each GLP study and final report before 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 and discontinued studies.
- Review and trend amended reports.
- Review duplicate reports.
- Initiate, investigate, resolve, and verify CAPAs.
- Review documents in MasterControl, including collaboration and approval activities.
- Review logbooks.
- Meet regularly with the Section Leader, Study Directors, and Lab Analysts.
- Prepare the Dashboard and Quarterly Management Review with the 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.
- Complete required training on time, including MasterControl, live company trainings, and New Employee Orientation.
- Know and follow company policies and procedures.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Education Level
Associate degree
