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Junior Compliance Auditor

2 months ago

Newark, Delaware, United States QPS, LLC Full time
Job Overview

QPS, LLC is a forward-thinking Contract Research Organization (CRO) dedicated to supporting pharmaceutical, biotechnology, and medical device firms in their drug development processes. We offer a comprehensive suite of GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services. For further details and to explore our current job openings, please visit our website.

Position Summary

Adherence to relevant regulatory standards is vital for our pharmaceutical partners, and our Quality Assurance Auditors play a crucial role in fulfilling these obligations. This entry-level position demands meticulous attention to detail, strong organizational skills, the ability to manage multiple tasks, and comfort in engaging with individuals across various levels of seniority.

Key Responsibilities

  • Safeguard client confidentiality and ensure that all audit-related documents are managed securely.
  • Examine QPS Standard Operating Procedures (SOPs) to confirm alignment with regulatory standards and interpretations.
  • Assess equipment and laboratory documentation, as well as Employee Qualification Manuals, to verify compliance with SOPs.
  • Review study documentation and reports to ensure they accurately represent the protocol, amendments, SOPs, procedures, and actual data collected during the study.
  • Compare analytical methodologies against the protocol and validated procedures to ensure appropriate study execution.
  • Identify instances of noncompliance and deviations, recommending corrective and preventive actions in a constructive and educational manner.
  • Prepare audit reports to communicate noncompliant findings to the Principal Investigator, Study Director, and Management, ensuring their follow-up actions are sufficient and complete to finalize the audit.
  • Support client and regulatory audits or any departmental objectives as directed by supervisors or managers.

Required Knowledge, Skills, and Abilities

  • Understanding of and compliance with GLP regulations, principles, and Guidance Documents.
  • Ability to identify resources and utilize them to develop solutions, make informed decisions, and implement them effectively.
  • Capacity to foresee and recognize critical issues or challenges and propose viable solutions.
  • Proficiency in managing conflicts and driving resolutions independently or through the appropriate chain of command.
  • Strong verbal and written communication skills.
  • Demonstrated ability to exercise sound judgment and effectively balance work responsibilities and shifting priorities.

Education and Experience

  • Bachelor's degree in Chemistry, Biochemistry, Pharmacology, or a related scientific field is preferred.
  • A minimum of three (3) years of experience in a regulatory environment or role (GLP, GCP, or GMP) is advantageous.
  • Experience with mass spectrometry chromatography and/or ELISA, along with familiarity with various laboratory equipment, is preferred but not mandatory.

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. Job applicants and current employees are assessed solely based on their abilities, experience, and job requirements. Additionally, QPS, LLC is a federal contractor and prioritizes referrals of protected veterans.