Senior QA Specialist

Summary:

Senior Quality Assurance Specialist contributes to Quality and Compliance oversight of all drug and device development and outcomes research, through the provision of qualification of technologies used in a clinical trial environment.

What you do?

• The Sr QA Specialist conducts internal and vendor audits to assure compliance with ICON SOPs, and applicable regulatory requirements.
• They also support Regulatory/Sponsor inspection/audit, case and Technical issues and other activities dependent on business needs.
• Conducts work with a limited degree of supervision
• Provide support, as needed, to global Quality & Compliance (Q&C) Department
• Supports quality, timeliness, and effectiveness initiatives, modifying work practices and processes, to achieve improvement results as needed
• Keep the person to whom the Quality Process Specialist reports informed of any quality issues within the department/office which require attention Provide guidance and advice to stakeholders of ICON's QA and regulatory requirements with regard to validation activities

What you need?

• Bachelors degree preferably from life science background
• 4-6 years of experience in QA on clinical validation projects from pharmaceutical, biotech or CRO industry.
• Excellent computer, documentation and communication skills are required