Quality Assurance Specialist II - Boston, MA area

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

What you will be doing:

• Track and trend all globally reportable complaints including initial, follow up and final reports.
• Liaise with compliance team (for all reports) and EU Authorised Rep (for EU reports) to ensure submission of all reports.
• Complete initial vigilance reports and others as needed.
• Manage process for vigilance assessments to ensure on time completion and escalation if required.
• Manage process for clinical complaints to ensure all steps completed in a timely manner.
• Work with IT to maintain workflow processes that support vigilance or complaint automation.
• Support process improvements in compliance activities (e.g., Argus/Complaint/DT process flow, audit preparation standardization, etc.)

You are:

• 5 years’ experience in pharmaceutical industry
• 3 years of documented Quality Control experience in pharmaceutical
• 4 year degree
• No travel.

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.