Lab QA Auditor I - GLP/GCP Compliance & Growth

QPS Holdings, LLC; Newark (DE); On-site; USD 45,000 - 50,000; Full time

Job summary

QPS, LLC in Newark, Delaware is seeking an Auditor I - Laboratory to join our Quality Assurance team. In this full-time role you will perform protocol, raw data, and report audits to ensure GLP, GCP, and GMP compliance, and you will report findings to Study Directors and management.

Candidates should have a related science degree and lab experience; no visa sponsorship is provided and applicants must be authorized to work in the U.S. on a permanent or unrestricted basis.

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

• Audit 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.

Education

Bachelor’s degree in a related scientific discipline

Job description

QPS, LLC in Newark, Delaware is seeking an Auditor I - Laboratory to join our Quality Assurance team. In this full-time role you will perform protocol, raw data, and report audits to ensure GLP, GCP, and GMP compliance, and you will report findings to Study Directors and management.

Candidates should have a related science degree and lab experience; no visa sponsorship is provided and applicants must be authorized to work in the U.S. on a permanent or unrestricted basis.