Quality Auditor I
About The Position
The Quality Auditor I 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.
Requirements
- 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
- At least 2 years of quality experience, with an associate degree preferred. Or 4 years of quality experience without the degree.
Responsibilities
- 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
- Perform good housekeeping (GHP) audits
- Perform other duties as assigned.
- Professional Development Complete required training on time (includes MasterControl, live company trainings, New Employee Orientation, etc.)
- Know and follow company policies and procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
