Senior QA Auditor — GLP Compliance Lead (Telework Eligible)

CareAbout; Columbia Township (MO); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Telework when applicable.

Training & Development Programs

Employee Referral Bonus Program

Job summary

Altasciences is seeking a Senior QA Auditor to perform independent audits of study-related activities and documents to ensure data integrity and compliance with GLP, 21 CFR Part 58 and Part 11, SOPs, and applicable regulations. The role includes mentoring staff and reporting findings to management.

The position requires a science degree, 2–3 years of GLP auditing experience, and familiarity with FDA regulations. Telework when applicable and a comprehensive benefits package are offered.

Qualifications

• Bachelor’s degree or higher in a scientific discipline or equivalent experience.
• 2–3 years related technical experience; minimum two years auditing in GLP environment.
• Certification such as RQAP-GLP or ASQ-CQA is recommended; not required.

Responsibilities

• Audits phases of nonclinical and laboratory studies, reports, and related duties to ensure regulatory compliance.
• Audits all disciplines (e.g., Method Validations, Non-Clinical GLP Studies).
• Performs in-life, process, vendor qualification, equipment and software validation audits.

Skills

Auditing

Regulatory knowledge

Microsoft Office

Education

Bachelor's degree in science

RQAP-GLP / ASQ-CQA (recommended)

Tools

GLP Regulations

Job description

Altasciences is seeking a Senior QA Auditor to perform independent audits of study-related activities and documents to ensure data integrity and compliance with GLP, 21 CFR Part 58 and Part 11, SOPs, and applicable regulations. The role includes mentoring staff and reporting findings to management.

The position requires a science degree, 2–3 years of GLP auditing experience, and familiarity with FDA regulations. Telework when applicable and a comprehensive benefits package are offered.