Auditor I

{"h1": "Job Title: Auditor I", "h2": "Job Summary", "p": "QPS, LLC is a Contract Research Organization (CRO) that provides GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services. As a junior-level QA Auditor, you will play a critical role in ensuring compliance with regulatory guidelines and requirements.

Responsibilities:

* Maintain client confidentiality and ensure controlled, protected, and secured documents.
* Audit QPS SOPs to ensure contents meet regulatory requirements and interpretations.
* Review equipment and laboratory records, and Employee Qualification Manuals to ensure compliance with SOPs.
* Audit study records and reports to ensure they accurately reflect the protocol/amendments, SOPs, procedures, and actual data results obtained during the study.
* Compare analytical procedures to the protocol and validated methods to ensure proper study conduct.
* Identify noncompliance and deviations, and recommend corrective and preventative actions in an educational and persuasive manner.
* Issue audit reports to disclose noncompliant findings to Principal Investigator, Study Director, and Management, and verify their follow-up responses are adequate and complete to close the audit.
* Assist with client and government audits or any department goals as requested by supervisor or manager.

Requirements:

* Bachelor\u2019s degree in Chemistry, Biochemistry, Pharmacology, or related scientific discipline.
* ≥ three (3) years experience working in a regulatory environment or position (GLP, GCP, or GMP).
* Experience in mass spec chromatography and/or ELISA and familiarity with various lab equipment are preferred but not absolute requirements.

QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. 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.

We are a federal contractor and desire priority referrals of protected veterans.
"}