QA Auditor II: GLP Compliance & Regulatory Inspections Lead

NorthernBio; Muskegon, Northern (MI, KY); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Northern Bio is seeking a QA Auditor II to support GLP policies across QA activities. The role involves ensuring study documentation, leading audits, and interacting with regulators. The candidate will work within the Quality Assurance Unit and may represent the company during sponsor inspections.

Requires a related Bachelor's degree, GLP knowledge, and QA experience; RQAP certification preferred. The position is full-time and on-site in Muskegon, MI, with potential for cross-site QA activities.

Qualifications

• Bachelor's degree or higher in a related discipline.
• RQAP certification preferred.

Responsibilities

• Ensure GLP studies are conducted per protocol and properly documented.
• Audit GLP, clinical, and method validation studies.
• Act as lead QA in multi-site studies when required.
• Maintain master schedules and assist annual facility audits.
• Interact with regulatory agencies and sponsors during inspections.

Skills

GLP knowledge

MS Office

Regulatory knowledge

QA experience

Education

Bachelor's degree

RQAP certification

Job description

Northern Bio is seeking a QA Auditor II to support GLP policies across QA activities. The role involves ensuring study documentation, leading audits, and interacting with regulators. The candidate will work within the Quality Assurance Unit and may represent the company during sponsor inspections.

Requires a related Bachelor's degree, GLP knowledge, and QA experience; RQAP certification preferred. The position is full-time and on-site in Muskegon, MI, with potential for cross-site QA activities.