Senior QA Compliance Auditor - GLP Early Drug Safety Assessment

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
  

Education/Qualifications

• 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
  

Experience

• 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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