Laboratory QA Auditor I – Career Growth & Incentives

Mary Dickson; Newark (DE); On-site; USD 65,000 - 95,000; Full time

Job summary

QPS, LLC in Newark, Delaware is seeking a Quality Assurance Auditor to perform protocol, raw data, and report audits for GLP, GCP and Part 11 compliance. You will report findings to Study Directors, Principal Investigators and facility management, contributing to continuous quality and regulatory readiness.

Applicants should have a related science degree, lab experience and familiarity with GMP/GxP environments.

Qualifications

• Bachelor’s degree in a related scientific discipline such as Biology, Biochemistry, Immunology, Analytical Chemistry preferred.
• Lab experience and/or experience working within GLP, GCP or GMP Quality Assurance preferred but not required.

Responsibilities

• The JobAudit scientific data for various clinical and nonclinical study records and reports to ensure proper study conduct and to ensure raw data results reflect the requirements specified in the respective protocol, SOP(s), validated method, study plan, lab manual and analytical procedure.
• Inspect lab work in situ to ensure compliant study procedures, facilities, equipment, personnel training, computer systems and respective raw data documentation.
• Audit and inspect the Quality Management System to identify any quality improvements necessary to maintain compliant quality systems.
• Identify areas of noncompliance and formulate recommendations for corrective and preventative actions necessary to improve quality and compliance.
• Issue audit reports to responsible scientists, personnel and Management for them to formally respond to Quality Assurance findings and recommendations.
• Verify audit report follow-up responses in order to close each audit issued.
• Assist with client and government audits and any department goals as directed by line management.
• After hours incentive work potential.

Skills

Lab experience

GLP/GCP/GMP QA

Auditing

Education

Bachelor’s degree in a related scientific discipline (Biology, Biochemistry, Immunology, Analytical Chemistry)

Job description

QPS, LLC in Newark, Delaware is seeking a Quality Assurance Auditor to perform protocol, raw data, and report audits for GLP, GCP and Part 11 compliance. You will report findings to Study Directors, Principal Investigators and facility management, contributing to continuous quality and regulatory readiness.

Applicants should have a related science degree, lab experience and familiarity with GMP/GxP environments.