Auditor I

Job Description Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? Our compliance with applicable regulatory guidelines and requirements is critical to our pharmaceutical clients. In the Quality Assurance role, you will use your scientific education, experience, and on-the-job training to perform protocol, raw data, and report audits for compliance with regulatory requirements (GLP, GCP & Part11), SOPs, and protocols. You will report all findings from the audits and inspections to Study Directors, Principal Investigators, Test Site Management, Test Facility Management, Operational Management, and scientific personnel. Responsibilities Audit scientific data for various clinical and nonclinical study records and reports to ensure proper study conduct and that raw data results reflect the requirements specified in the protocol, SOP, 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 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 to close each audit issued. Assist with client and government audits and any departmental goals as directed by line management. Work 100% at the QPS office/facility. Requirements Bachelor’s degree in a related scientific discipline such as Biology, Biochemistry, Immunology, or Analytical Chemistry. Lab experience and/or experience working within GLP, GCP or GMP Quality Assurance is preferred but not required. Authorized to work in the U.S. on a permanent or unrestricted basis; no visa sponsorship will be provided. Benefits and Opportunities Bonuses and merit increases tied to individual, team, and company performance. Solid benefits package, including company‑matched 401(k) and company‑sponsored Group Life/AD&D and Short and Long‑term Disability Insurance. Park‑like setting in Newark, Delaware. Structured career ladder with excellent growth opportunities. Equal Employment Opportunity Statement QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. QPS, LLC is a federal contractor and desires priority referrals of protected veterans. #J-18808-Ljbffr Mary Dickson