Quality Auditor (Day Shift)

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.

Education and experience requirements:


* Associate's degree and 2 years of relevant experience
+ OR


* Bachelor's Degree (Relevant Life Science preferred, Microbiology, Biology, etc.)
+ OR


* 4+ years of directly relevant Quality Assurance background

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

Nelson offers a competitive benefits package that includes:


* Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts


* 401(k) program with Company match that immediately vests


* Paid holidays, vacation and sick time


* Free financial planning assistance


* Paid parental leave


* Education assistance


* Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance


* Employee Assistance Program (EAP)

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.The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry.

With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technolo...