Lab QA Auditor - GLP/GCP Compliance

Qps-Holdings,-LL; 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 perform audits of study records, data and reports for GLP/GCP compliance. You will inspect lab work, verify procedures and ensure accuracy of raw data in alignment with protocols and SOPs.

The role requires a bachelor’s degree in a related science; GLP/GCP/GMP QA experience is preferred but not required. This is a full-time, on-site position with opportunities for professional growth and involvement in client and regulatory

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.

Skills

Audit

Quality Assurance

Lab procedures

Regulatory compliance

Education

Bachelor’s degree in biology/related field

Job description

QPS, LLC in Newark, Delaware is seeking an Auditor I – Laboratory to perform audits of study records, data and reports for GLP/GCP compliance. You will inspect lab work, verify procedures and ensure accuracy of raw data in alignment with protocols and SOPs.

The role requires a bachelor’s degree in a related science; GLP/GCP/GMP QA experience is preferred but not required. This is a full-time, on-site position with opportunities for professional growth and involvement in client and regulatory