GLP QA Auditor II: Compliance, Inspections & CAPA Lead

Northern Biomedical Research Inc; Muskegon (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Northern Biomedical Research Inc invites applications for QA Auditor II to support GLP policies across the Quality Assurance Unit. The role may represent the company during sponsor and regulatory inspections.

Responsibilities include auditing GLP studies, protocols, amendments, and study reports, plus leading QA in multi-site projects and assisting in facility audits and archive management.

Qualifications

• Bachelor’s degree in a related discipline.
• 3+ years QA support of GLP studies preferred.
• RQAP certification from SQA preferred.
• Proficiency with Microsoft Office core applications and the ability to learn and use additional applications.
• Knowledge of GLPs and other federal regulations relating to laboratory sciences.
• Experience with Computer System Validation and 21 CFR Part 11.

Responsibilities

• Audit GLP, Clinical, and Method Validation studies to ensure compliance with protocol and documentation.
• Audit Protocols and Amendments as required.
• Audit in-process phases of GLP studies, Clinical Studies, and Method Validations.
• Review study reports for GLP, Clinical, and Method Validation to ensure data integrity.
• Lead QA in a multi-site study.

Skills

Microsoft Office

GLP knowledge

Regulatory compliance

Written & verbal communication

Time management

Education

Bachelor’s degree in a related discipline

Tools

Computer System Validation

21 CFR Part 11

Job description

Northern Biomedical Research Inc invites applications for QA Auditor II to support GLP policies across the Quality Assurance Unit. The role may represent the company during sponsor and regulatory inspections.

Responsibilities include auditing GLP studies, protocols, amendments, and study reports, plus leading QA in multi-site projects and assisting in facility audits and archive management.