Quality Assurance Specialist II

As a Quality Assurance Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Participate in CQA induction activities for newcomers and provide training to the CQA team on the Quality Management System and the Audit workflow
• Provide operational guidance to CQA team for data creation and management in CQA’s Quality Management System
• Support with tracking and timely Corrective and Preventative Action (CAPA) closure
• Ensure accurate data entry of GCP audit reports and associated responses, CAPAs and effectiveness checks in the Quality Management System
• Support in performing centralized cross-program Quality Control activities and data cleaning of QMS data relating to audit activities
• Generate audit data and CQA quality metrics reports from the Quality Management System and other related tools for ad hoc request, analysis and reporting
• Manage the CQA Audit Operations shared mailbox and CQA central data repository
• Escalate systemic and/or critical problems to Head, GCP Audit Operations, GCP Compliance and CQA management
• Participate in GCP health authority inspections as it relates to data in the CQA Quality Management System or central repositories and other support activities
• Support with CQA Training matrices and SOP lifecycle management
• Contribute to development and improvement of audit related processes and templates
• Other CQA GCP compliance support activities, as required

You are:

• BA/BS degree required. Degree in scientific discipline preferred
• Minimum of 1 year of experience in the pharmaceutical, biotechnology or related health care industry
• Minimum 1 year of GCP-related Quality Assurance or relevant clinical trial experience preferred
• Knowledge and experience in GCP, quality, and compliance to conduct responsibilities with input and direction, as needed, from supervisor and other CQA team members
• Understanding of GCP audit conduct and reporting an advantage
• Collaborative team player with a positive attitude that desires to learn and develop in CQA
• Ability to communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing.
• Able to prioritize and manage multiple projects and demanding timelines
• Attention to detail and ability to analyse complex data

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.