Lead Quality Assurance Auditor

2 weeks ago


Austin, Texas, United States Worldwide Clinical Trials Full time
Position Overview:

The Senior Auditor plays a pivotal role in ensuring compliance with regulatory standards and internal protocols within our organization. As a member of the Quality Assurance team, you will be responsible for conducting thorough audits and providing essential guidance on regulatory adherence.


About Us:

Worldwide Clinical Trials is a globally recognized mid-sized Contract Research Organization (CRO) dedicated to advancing healthcare through innovative clinical solutions. Our team comprises nearly 3,500 skilled professionals committed to excellence and quality in every aspect of our work.


Key Responsibilities:
  • Conduct comprehensive audits to evaluate compliance with GxP regulations and internal procedures.
  • Prepare detailed reports on audit findings and provide actionable recommendations.
  • Collaborate with the QA team to develop and implement corrective and preventive action plans (CAPAs).
  • Maintain accurate records of audit activities and ensure timely follow-up on identified issues.
  • Assist in training and mentoring junior team members on quality assurance practices.

Qualifications:

The ideal candidate will possess a Bachelor's degree in a scientific discipline and have a minimum of five years of relevant experience in quality assurance, regulatory affairs, or clinical research. A strong understanding of GxP regulations and the ability to interpret complex technical documents is essential.


Skills Required:
  • Exceptional analytical and problem-solving abilities.
  • Strong organizational skills with the capacity to manage multiple projects simultaneously.
  • Excellent communication skills, both written and verbal.
  • Ability to adapt to changing priorities and work effectively in a dynamic environment.

Our Commitment:

At Worldwide Clinical Trials, we are committed to fostering an inclusive workplace that values diversity and promotes collaboration. We believe that a diverse workforce enhances our ability to innovate and deliver exceptional results for our clients.



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