Associate Validator II

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks. • Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents. • Create and execute validation test scripts as requested and document the test results. • Ensure quality of work. • Prioritize workload to meet specified completion dates. • Assist with the maintenance of validation metrics. • Carry out all activities according to Fortrea Standard Operation Procedures (SOPs) and project specific conventions within the framework of Quality Management and Good Clinical Practice (GCP)/ICH guidelines. • Maintain accurate records of all work performed. • Perform other duties as assigned by management.

🎯 Requirements

• University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution. • Fluent in English, both written and verbal. • 3 years of validation experience working with a global CRO/Pharma. • A neat, methodical, and thorough approach to the work with an emphasis on attention to detail. • Good concentration skills are required to meet the consistently high standards expected. • Self-motivation with the ability to work under pressure to meet demanding deadlines. • Effective communication skills and the ability to work as part of a team. • Flexibility – being able to move from one computer system to another with ease and adapt to modern technology and a constantly changing work environment.

🏖️ Benefits

• Home based