GLP QA Auditor II – Compliance & Audit Lead

NORTHERN BIOMEDICAL RESEARCH INC dbaNorthernB; Muskegon (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

NORTHERN BIOMEDICAL RESEARCH INC dbaNorthernB is seeking a QA Auditor II to support GLP policies and regulatory inspections, ensuring documentation supports study findings and compliance during sponsor visits. The role involves auditing protocols, study reports, and CAPA tracking, maintaining archives, and collaborating with facilities, with a focus on 80% office and 20% lab work.

A related bachelor’s degree is required.

Qualifications

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

Responsibilities

• Assure GLP, Clinical, and Method Validation studies meet protocol regulations and have adequate 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 studies.
• Act as lead QA in multi-site studies.
• Maintain Master Schedule and annual Facility Audit.
• Conduct process-based audits and SOP reviews.
• Interact with regulators and sponsors during inspections.

Skills

GLP regulations knowledge

Regulatory inspections

Documentation & record-keeping

Microsoft Office proficiency

Time management

Education

Bachelor’s degree in a related discipline

Tools

Microsoft Office

Job description

NORTHERN BIOMEDICAL RESEARCH INC dbaNorthernB is seeking a QA Auditor II to support GLP policies and regulatory inspections, ensuring documentation supports study findings and compliance during sponsor visits. The role involves auditing protocols, study reports, and CAPA tracking, maintaining archives, and collaborating with facilities, with a focus on 80% office and 20% lab work.

A related bachelor’s degree is required.