Quality Assurance Auditor I

Quality Assurance Auditor I

Requirements

• Quality control and/or quality assurance experience with a focus on Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GLCP)
• 2+ years of industry experience
• Bachelors degree in the field of healthcare or science or equivalent experience
• Strong attention to detail and organizational skills, with the ability to prioritize tasks effectively
• Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams and stakeholders
• Ability to work onsite in Whitesboro, NY an average of 3 days per week

Responsibilities

• Perform tasks relevant to the assigned Quality & Compliance (Q&C) function which may include but not limited to conducting internal and vendor audits, External audits/inspections management, SOP and documentation review, and CAPA management
• Be familiar with all relevant SOPs, with ICH-GCP, and relevant regulations and guidelines
• Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate
• Recognize, exemplify, and adhere to ICON’s values which center on Integrity, Accountability & Delivery, Collaboration, Partnership, and Own It @ ICON
• Embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
• Coordinate and lead internal audits including but not limited to conducting contracted, project, process, facility, self-inspection, and vendor audits
• Facilitate client audits and regulatory inspections of ICON and investigational sites (if applicable) and ensure that the client auditors and inspectors receive access to needed documentation and staff
• Effective CAPA Management according to ICON processes and Regulation
• Support Operations with investigations, Root Cause Analysis (RCA), and resulting CAPA management of ICON audit findings
• Assist with the implementation and maintenance of an effective Quality Management System / Quality Assurance program
• Travel up to 35% (domestic and/or international) which may increase based on business needs

Preferred Qualifications

• Bioanalytical Lab experience (preferred)