[Hiring] Associate Validator II @Fortrea

Role Description

Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks to include receiving and logging-in and scanning contractual and validation documentation. Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents.

• Serves as a member of the project team with primary responsibilities for all documentation requirements to support global EDC solutions tasks.
• Assist project teams with validation tasks as requested.
• Assist with creation, production, printing and tracking of study documents and other controlled documents as needed.
• 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.
• Assist with special projects as designated.
• And all other duties as needed or assigned.

Qualifications

• University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Requirements

• 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.

Physical Demands/Work Environment

• Home based