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Job Details

Labcorp (Drug Development)

Senior QA Compliance Auditor - GLP Early Drug Safety Assessment

Business and Financial Operations


Full Time

On Site


Somerset, New Jersey, United States

Do you have GLP/GCP auditing experience? If so, we want you to join our Global QA team as a Senior QA Compliance Auditor in Somerset, NJ.

Labcorp Drug Development’s work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.

We are offering a sign-on bonus of $5,000 (paid after 60 days of employment; external candidates only)

Position Overview

  • Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution

  • Report on relevant quality metrics (for multiple topics/departments) and highlight trends

  • Provide consultation to the operational team (e.g. as they revise/write controlled documents)

  • Delivery of training in performance of audits (basic, intermediate audit activities)

  • Work with operational management to support Quality topics and/or working on projects with QA team on other sites (showing development of collaboration skills)

  • Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization

  • Create and/or re-write QA SOPs based on findings from local quality initiatives.

  • Organizing, Prioritizing and Managing all aspects of workload to meet business needs.

  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed


  • A minimum of a Bachelor’s Degree in a Pharmacy, Chemistry or Biology related discipline

  • Postgraduate degree (MSC or equivalent) in science or management related discipline, preferable

  • Experience may be substituted for education


  • 6 years’ in regulatory environment (experience in GLP/GCP roles preferred)

  • Knowledge of industry quality systems/standards and able to apply (applicable) regulations in order to monitor compliance

  • Experienced GLP/GCP auditor

  • Excellent interpersonal/organizational skills, e.g. communication, decision making, negotiating, problem solving

  • Able to influence QA strategy systems/standards and ability to apply appropriate regulatory knowledge to multiple scenarios

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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