Senior QA Auditor

Talent; Muskegon (MI); On-site; USD 65,000 - 95,000; Full time

Job summary

Talent in Muskegon, MI is hiring a Senior Quality Assurance Auditor to join a growing life sciences organization. You’ll lead GLP study audits, review protocols, and support regulatory inspections in a compliant, fast-paced environment.

The role emphasizes independence and collaboration with scientific teams, focusing on data integrity, 21 CFR Part 11, and CAPA processes. Onsite office with regulated lab exposure and PPE provided.

Qualifications

• Bachelor’s degree in a related science or technical field.
• 3+ years QA experience supporting GLP studies.
• Strong understanding of GLP regulations and lab operations.
• Experience auditing study protocols, data, and reports.
• Familiarity with 21 CFR Part 11 and Computer System Validation is a plus.

Responsibilities

• Perform QA audits across GLP studies, clinical studies, and method validations.
• Review study protocols, amendments, raw data, and final reports for accuracy and compliance.
• Conduct in-process, facility, and process-based audits.
• Support sponsor visits and regulatory inspections.
• Partner with study teams to ensure compliance with GLP requirements and internal procedures.
• Support deviation tracking, CAPAs, and process improvement initiatives.
• Assist with Computer System Validation and 21 CFR Part 11 compliance.
• Review SOPs and contribute to employee GLP training.
• Participate in supplier qualification and multi-site study activities.
• Support study documentation and archive management.

Skills

QA auditing

GLP compliance

Documentation

Communication

Independent work

Education

Bachelor’s degree in a related scientific or technical discipline

Job description

We’re hiring for a Senior Quality Assurance Auditor to join a growing life sciences organization!

This is a great opportunity for someone with a GLP Quality Assurance background who wants to take on meaningful responsibility across study auditing, regulatory compliance, and continuous improvement.

Location: Muskegon, MI

Schedule: Full-time, onsite

What you’ll be doing:

• Perform QA audits across GLP studies, clinical studies, and method validations
• Review study protocols, amendments, raw data, and final reports for accuracy and compliance
• Conduct in-process, facility, and process-based audits
• Support sponsor visits and regulatory inspections
• Partner with study teams to ensure compliance with GLP requirements and internal procedures
• Support deviation tracking, CAPAs, and process improvement initiatives
• Assist with Computer System Validation and 21 CFR Part 11 compliance
• Review SOPs and contribute to employee GLP training
• Participate in supplier qualification and multi-site study activities
• Support study documentation and archive management

What we’re looking for:

• Bachelor’s degree in a related scientific or technical discipline
• 3+ years of Quality Assurance experience supporting GLP studies preferred
• Strong understanding of GLP regulations and laboratory operations
• Experience auditing study protocols, data, and reports
• Knowledge of 21 CFR Part 11 and Computer System Validation is a plus
• RQAP certification is a plus, but not required
• Strong communication, organization, and documentation skills
• Someone who is comfortable working independently while collaborating closely with scientific and operational teams

This position will primarily work in an office environment with some time spent within the laboratory, so candidates should be comfortable working in a regulated laboratory setting and wearing required PPE.