Quality Auditor

The Quality Auditor reviews GLP studies for completeness, compliance, concurrence, and accuracy.

The auditor provides regulatory and policy and procedural guidance to the lab staff.

Additionally, the auditor collaborates with lab personnel in design, implementation, and performance of testing with the goal of improving and building quality into the process.

Essential job functions:

GLP Studies


* Review each GLP study prior to release for testing.


* Audit a portion of each GLP study to ensure compliance with regulations, standards, and procedures.


* Review each GLP study and final report prior to mailing.


* Assist quality staff and lab staff in quality trend analysis.


* Perform internal process audits.

Regulatory and Policy & Procedural Guidance


* Know and follow GLP, GMP and relevant ISO regulations


* Review and trend quality events (deviations and non-conformances, CAPA)


* Review out of range events


* Review discontinued studies


* Review and trend amended reports


* Review duplicate reports


* CAPA: Initiation, investigation, resolution, and verification


* Review standard procedure 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 and review in-process testing and data


* Assist QA Regulatory with internal audits


* Review validation protocols, raw data, and reports

Perform other duties as assigned.

Job requirements:


* Attention to detail


* Proficient verbal & written communication skills


* Ability to work independently


* Decision making/problem solving - creating win/win situations


* Time management- response time, meeting deadlines


* Excellent customer service/interpersonal skills


* Ability to multi-task


* Self-motivated/initiative


* Conflict management- diffusing situation and creating win/win situations


* Follow instructions/assist others in following instructions


* Presentation skills/public speaking for dashboards


* Project management (infrequent, but needed)


* Haveegible handwriting


* Computer skills ( Microsoft Word and Excel)


* Dependable

Physical requirements:

Must be able to stand/walk for 10% of the day and 90% of the day sitting at a desk or on the computer.

Must be able to occasionally lift a maximum of 45lbs.

Education and experience requirements:

A.A.

/ A.S.

and two years applicable NLI laboratory experience OR B.S.

(Microbiology or biological science strongly preferred or NLI equivalent) OR four years applicable NLI laboratory experience in addition to demonstrated proficiency for attention quality.