Auditor I

About the role

Perform protocol, raw data, and report audits for compliance with regulatory requirements (GLP, GCP & Part 11), SOPs, and protocols. Ensure proper study conduct and raw data results align with specified requirements. Inspect lab work and facilities to ensure compliance with study procedures, equipment, personnel training, and documentation. Audit and inspect the Quality Management System to identify quality improvements. Issue audit reports and verify follow-up responses to close audits. Assist with client and government audits and departmental goals.

Responsibilities

• Audit and inspect clinical and nonclinical study records and reports for compliance with protocols, SOPs, and methods.
• Inspect lab work in situ to ensure adherence to study procedures, facilities, equipment, personnel training, and raw data documentation.
• Audit and inspect the Quality Management System to identify quality improvements.
• Identify and report noncompliance issues and recommend corrective and preventive actions.
• Issue audit reports to relevant parties and verify follow-up responses.
• Assist with client and government audits and departmental goals.

Requirements

• Bachelor’s degree in a related scientific discipline such as Biology, Biochemistry, Immunology, or Analytical Chemistry.
• Lab experience and/or experience working within GLP, GCP, or GMP Quality Assurance.

Qualifications

While a degree in a related scientific discipline is preferred, lab experience and/or experience within GLP, GCP, or GMP Quality Assurance is preferred but not required.

Skills

Strong attention to detail, scientific knowledge, and proficiency in auditing and reporting are essential skills for this role.

Benefits

QPS offers a comprehensive benefits package including a company-matched 401(k), group life/AD&D and short and long-term disability insurance, and a park-like setting in Newark, Delaware. Additional benefits include structured career ladders, bonuses, and merit increases tied to individual, team, and company performance.

Pay

Details on pay are not specified in the job posting.

Schedule

The job is 100% office/facility based.