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About the Role
Ensure the accuracy, reliability, and compliance of laboratory processes and systems supporting clinical trials.
Responsibilities
- Take responsibility for quality assurance and compliance deliverables, applying skills to ensure quality and efficiency.
- Collaborate with laboratory and quality assurance teams to develop and execute validation protocols and test plans for laboratory instruments, equipment, and software systems.
- Conduct validation testing, data analysis, and documentation in accordance with regulatory requirements and industry standards.
- Identify and troubleshoot validation issues, deviations, and non-conformances, and implement corrective and preventive actions.
- Provide technical expertise and guidance on validation strategies, best practices, and regulatory expectations to project teams and stakeholders.
- Contribute to the continuous improvement of laboratory processes, systems, and validation methodologies.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or related field.
- Minimum of 2 years of experience in laboratory validation, quality assurance, or related role within the pharmaceutical, biotechnology, or clinical research industry.
- Strong understanding of regulatory requirements (e.g., FDA, EMA, ICH) governing laboratory operations and validation activities.
- Proficiency in validation methodologies, documentation practices, and quality management systems.
- Excellent analytical, problem-solving, and communication skills, with the ability to work effectively in a cross-functional team environment.
- Willingness to travel as required (approximately 5%).
- Must have the legal right to work in the country where the role is based.
Skills
- Quality assurance
- Compliance
- Validation protocols
- Test plans
- Data analysis
- Troubleshooting
- Corrective and preventive actions
- Technical expertise
- Analytical skills
- Problem-solving skills
- Communication skills
- Cross-functional team collaboration
Location
- Farmingdale NY
Work Type
- Office-based
- On-site
Experience Level
- Minimum of 2 years of experience
Education Level
- Bachelor's degree
Salary/Compensations
- $62,376.00-$77,970.00
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
About the Company
- ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
- As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Equal Opportunity
- ICON is an equal opportunity employer.
- We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
- If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.