Quality Assurance Auditor II

Job overview

The Quality Assurance Auditor II works onsite in Muskegon, Michigan. Compensation is not specified. The role supports Northern Bio’s Quality Assurance Unit and its Good Laboratory Practice program. The auditor helps ensure GLP, clinical, and method-validation studies follow applicable requirements and have adequate documentation. Through audits, inspection support, and archive management, the role contributes to reliable study records and regulatory compliance.

What you'll do

• Audit protocols, amendments, study phases, and reports
• verify study documentation and raw-data representation
• serve as lead QA on multi-site studies
• maintain the master schedule
• assist with facility and process-based audits
• review standard operating procedures
• interact with sponsors and regulatory agencies during inspections
• maintain archive records and coordinate study-material disposition.

What we're looking for

Skills & competencies

quality assurance auditor ii

muskegon mi

full-time

good laboratory practice

glp audits

clinical studies

method validation

regulatory inspections

study archives

fda regulations

northern bio

Work arrangement

• Weekend coverage required

Why this role

May represent the company during sponsor and regulatory inspections; the role includes approximately 80% office work and 20% laboratory work, with exposure to animal pathogens, chemicals, animal tissue, and zoonotic organisms.

About the employer

NORTHERN BIOMEDICAL RESEARCH INC dbaNorthernB is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.