Auditor I Laboratory

Mary Dickson; Newark (DE); On-site; USD 65,000 - 95,000; Full time

Job summary

QPS, LLC in Newark, Delaware is seeking a Quality Assurance Auditor to perform protocol, raw data, and report audits for GLP, GCP and Part 11 compliance. You will report findings to Study Directors, Principal Investigators and facility management, contributing to continuous quality and regulatory readiness.

Applicants should have a related science degree, lab experience and familiarity with GMP/GxP environments.

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

• The JobAudit 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

Lab experience

GLP/GCP/GMP QA

Auditing

Education

Bachelor’s degree in a related scientific discipline (Biology, Biochemistry, Immunology, Analytical Chemistry)

Job description

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! Our compliance with applicable regulatory guidelines and requirements is critical to our pharmaceutical clients. In the Quality Assurance role, you will put your scientific education, experience and on-the-job training to work by performing protocol, raw data, and report audits for compliance with regulatory requirement (GLP, GCP & Part 11), SOPs, and protocol, reporting all findings from the audits and inspections to Study Directors, Principal Investigators, Test Site Management, Test Facility Management and Operational Management and scientific personnel.No visa sponsorship (e.g. H‑1B, L‑1, E) will be provided for this active position, now or in the future. Applicants must currently be authorized to work in the U.S. on a permanent or unrestricted basis.

QPS’ Story:

Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, Early Phase Clinical and Phase II – IV Clinical Research services. To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.Team members enjoy challenging and rewarding work, and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, team work and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.

Work Location

This job will be 100% QPS-office/facility based

Requirements

• 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.

Why You Should Apply

Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.

Structured Career Ladders that provide excellent growth based on your personal aspirations.

Bonuses and merit increases are a part of the QPS total rewards approach and are linked 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.

Internal committees designed with the needs and enjoyment of QPS employees in mind.

Responsibilities

• The JobAudit 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.

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. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.