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Quality Assurance Intern H/F

3 months ago

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Position Overview:
As a Quality Assurance Intern at ICON Strategic Solutions, you will become part of a leading global clinical research organization, driven by healthcare insights.

Your Responsibilities:
As an intern, you will be the primary contact for inquiries related to quality and compliance, collaborating with the Quality Assurance team to ensure consistent communication and alignment with Good Clinical Practice (GCP) and regulatory standards.

  • Assist in identifying and escalating potential risks, while developing plans to mitigate them.
  • Provide training support to study teams as necessary.
  • Help prepare teams for regulatory inspections, including those from sponsors, countries, sites, and vendors.
  • Ensure compliance with GCP and maintain quality standards as the global point of contact for sponsor study documentation.
  • Support ongoing studies and submissions to uphold overall quality.
  • Collaborate with teams to resolve quality issues with Contract Research Organizations (CROs) and guide them back to compliance.
  • Contribute to the communication of lessons learned and propose process improvements based on these insights.
  • Review significant findings from Quality Assurance audit reports and suggest enhancements to processes.
  • Assist teams in developing Corrective and Preventive Actions (CAPA).
  • Work with Quality Assurance to gather necessary information for global inspections.
  • Support the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WIs).
  • Engage in operational diagnostics to pinpoint areas for improvement.
  • Provide input for Quality Plans and track progress on improvement initiatives.
  • Foster relationships with process experts to facilitate improvement activities.
  • Stay updated on clinical trial requirements and guidelines from regulatory agencies.
  • Become well-acquainted with assigned compounds and protocols.
  • Facilitate collaboration among cross-functional stakeholders.

Qualifications:
To succeed in this role, you should possess the following:

  • Problem-solving skills and a leadership mindset aimed at continuous improvement.
  • Knowledge of relevant procedures and a strong customer service orientation.
  • Ability to work collaboratively with key stakeholders.
  • Experience in managing complex operational challenges.
  • Strong verbal and written communication skills, effective at all organizational levels.
  • Broad understanding of Clinical Operations.
  • Attention to detail.
  • A Bachelor’s degree.
  • A minimum of 5 years of experience in a quality role within a pharmaceutical, bio-pharmaceutical, or Contract Research Organization.
  • Familiarity with Clinical Operations activities and experience with sponsor/site audits.
  • Experience in developing processes, SOPs, and WIs.
  • Prior experience with regulatory inspections is preferred.
  • Willingness to travel as required.

Why Choose ICON?
At ICON, we are dedicated to providing a comprehensive and competitive rewards package, which includes not only a competitive salary but also a variety of variable pay and recognition programs. Our exceptional employee benefits and supportive policies are designed to assist you and your family throughout your career journey.

We believe that our success is rooted in the knowledge, capabilities, and quality of our workforce. Therefore, we are committed to fostering a culture of continuous learning, where you will be challenged with engaging work that contributes to your professional growth.

ICON is an equal opportunity employer, committed to creating a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment.

If you require reasonable accommodation due to a medical condition or disability during the application process or to perform essential job functions, please inform us.

We encourage you to apply even if you do not meet all the requirements, as you may be the perfect fit for this or other roles at ICON.