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Onsite - Qa Compliance Auditor, Gcp

4+ years
Not Disclosed
10 June 11, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

QA Compliance Auditor – GCP (On-Site) | Dallas, TX

Job Summary:

Fortrea, a global leader in Contract Research Organization (CRO) services, is hiring a QA Compliance Auditor – GCP for its Dallas, TX facility. This on-site, full-time role focuses on supporting Early Phase Clinical Research by ensuring regulatory compliance through internal and external audits, training delivery, and quality assurance consultation. Join Fortrea to contribute towards global drug development and make a lasting impact in the clinical research industry.


Key Responsibilities:

  • Conduct internal and external audits as per audit activity plans.

  • Develop and deliver quality training to operational teams.

  • Guide operational teams on Quality Assurance (QA) and compliance matters.

  • Review and approve Quality documentation, including investigations and CAPA plans.

  • Foster cross-site QA and operational collaboration to enhance compliance and efficiency.

  • Support Quality-related projects and initiatives across multiple sites.

  • Drive local Quality initiatives to improve the performance of the QA organization.

  • Ensure adherence to Regulatory Compliance and Quality Assurance procedures.

  • Complete additional duties as assigned.


Required Skills & Qualifications:

  • Bachelor’s degree in Life Sciences preferred (or equivalent experience).

  • Minimum 4 years’ experience in a regulatory/GXP environment.

  • Proven experience as a GXP Auditor.

  • Ability to influence and shape QA strategies.

  • Knowledge of clinical research organizations and processes beneficial.

  • Flexibility to work overtime and weekends as required.

  • Strong communication, training, and collaboration skills.


Perks & Benefits:

  • Competitive salary (Not Specified).

  • Comprehensive medical, dental, vision, life, STD/LTD insurance.

  • 401(K) retirement savings plan.

  • Paid time off and employee recognition awards.

  • Access to Employee Resource Groups (ERGs).

  • Opportunities for professional growth in a leading global CRO.


Company Description:

Fortrea is a top global Contract Research Organization (CRO) providing cutting-edge clinical development and technology solutions to pharmaceutical, biotechnology, and medical device companies across more than 20 therapeutic areas. With operations in nearly 100 countries, Fortrea is committed to advancing healthcare innovation worldwide.


Work Mode:

On-Site – Dallas, Texas


Call to Action:

Ready to advance your career in clinical research quality assurance? Apply now to join Fortrea’s industry-leading team in Dallas, TX, and contribute to shaping the future of global drug development..