Lab QA Auditor I – Early Career in Pharma Quality

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

Benefits offered by this job

Bonuses

Career ladder

401(k) matching

Life/AD&D insurance

Disability insurance

Park-like setting

Job summary

QPS, LLC in Newark, Delaware is seeking an Auditor I - Laboratory to audit scientific data from clinical and nonclinical studies, ensuring raw data and reports meet the protocol, SOPs, validated method, and study plan requirements.

The role involves inspecting lab work, evaluating the Quality Management System, identifying noncompliance, issuing audit reports, and tracking corrective actions with management. After-hours incentive work is possible.

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 such as Biology, Biochemistry, Immunology, Analytical Chemistry preferred.

Job description

QPS, LLC in Newark, Delaware is seeking an Auditor I - Laboratory to audit scientific data from clinical and nonclinical studies, ensuring raw data and reports meet the protocol, SOPs, validated method, and study plan requirements.

The role involves inspecting lab work, evaluating the Quality Management System, identifying noncompliance, issuing audit reports, and tracking corrective actions with management. After-hours incentive work is possible.