QA Auditor I: GLP/GCP Compliance & Quality Assurance

QPS Holdings, LLC; Newark (DE); On-site; EUR 62,000 - 88,000; Full time

Benefits offered by this job

401(k)

Life Insurance

Disability Insurance

Job summary

QPS, LLC is seeking a QA Auditor to perform rigorous audits of protocols, raw data, and reports to ensure GLP/GCP/GMP compliance. The role involves inspecting lab work, reviewing the Quality Management System, and issuing findings to study directors and management.

The candidate should hold a related scientific degree and may participate in after-hours audits. This 100% on-site position is based at our Newark, Delaware facility, with opportunities to contribute to continuous quality improvements

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 data

Quality assurance

Regulatory compliance

Documentation

Education

Bachelor's degree in Biology/related

Job description

QPS, LLC is seeking a QA Auditor to perform rigorous audits of protocols, raw data, and reports to ensure GLP/GCP/GMP compliance. The role involves inspecting lab work, reviewing the Quality Management System, and issuing findings to study directors and management.

The candidate should hold a related scientific degree and may participate in after-hours audits. This 100% on-site position is based at our Newark, Delaware facility, with opportunities to contribute to continuous quality improvements