ONSITE - QA Compliance Auditor, GCP - Dallas, Texas

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.

We are currently seeking a QA Compliance Auditor - GCP, to lead and support our Clinical Pharmacology Start-up team in initiating Early Phase clinical trials for our clients with maximum speed and efficiency.

This is a full-time, office-based position in Dallas, Texas.

If you join us, you will work with some of the worlds leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

Summary of Responsibilities:

• Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample).
• Conducting Internal and External audits.
• Development and delivery of training (to operational groups).
• Delivery of training in performance of audits (basic, intermediate audit activities).
• Provide consultation to the operational team on Quality Issues.
• Review and approval of Quality documentation, including investigation and CAPA plans.
• Cross-site QA and operational relationship, provide recommendations for improving compliance and/or efficiency.
• Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills].
• Manage local Quality initiatives aimed at improving compliance and/or efficiency of the local QA organization.
• Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• A bachelor's degree in Life Sciences preferred (or equivalent Life Science experience).
• Experience may be substituted for education.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• 4 years in regulatory environment (experience in GXP roles).
• Experience as an auditor (GXP).
• Ability to influence QA strategy.
• Knowledge of clinical organization beneficial.

• Physical Demands/Work Environment:

• Some overtime and weekend work may be required.

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Learn more about our EEO & Accommodations request here.