Job Overview :
Get ready to redefine what’s possible and discover your extraordinary potential at Covance by Labcorp Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view.
With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients and your career.
COVANCE by Labcorp is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We have an exciting opportunity available to join our team.
We are currently recruiting an Validation Analyst in Costa Rica
Leads validation projects as assigned and serve as a validation team member on multiple assignments as designated by the management with support from other team members as needed.
Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks to include creating, reviewing and executing of validation documentation.
Review Scope of work for the assigned project.
Manage validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix, and Validation Report.
Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents.
Provide coordination of virtual global validation teams as needed to complete validation projects.
Maintains and utilizes a strong knowledge of SOPS and validation work procedures / standards in relation to the Validation tasks.
Demonstrate the ability to multi-task and manage validation activities for a project effectively.
Create and Execute validation test scripts and document the test results.
Plan and establish timelines to meet or exceed client expectation for validations.
Review clinical project specification documentation to create appropriate testing methodologies.
Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to Validation process.
Write and review validation documentation to support projects.
Work with other team members to create appropriate testing environments to support testing methodologies.
Conduct Peer Review / Quality control of study design for assigned projects
Utilize strong working knowledge of SOPs, validation standards, and work procedures to suggest potential improvements and to provide training and guidance to all critical staff.
Assist in the support of regulatory and client audits of validation activities and documents.
Support management of metrics.
Assist with investigating or resolving issues of patient safety or quality as directed.
Understand implications of activities on project budgets.
Suggest process improvements at various levels of validation process.
Assist in developing key metrics for process improvement.
Train, Mentor and support the team in their understanding and adoption of validation concepts and responsibilities.
Active member of SOP review team as assigned.
Lead or assist with special projects as designated.
Perform other duties as assigned by management.
Education / Qualifications :
University / college degree (life science, computer science, pharmacy or related subject preferred)
Concrete Spotfire experience
Certification in a related profession from an appropriately accredited institution (e.g., Certificate in Testing, SAS Certification) is an added advantage
Basic logical and reasoning skills.
Basic knowledge of the CRO industry.
Basic knowledge of drug development process and Clinical Data Management System.
Basic knowledge of relational databases preferred
Fluent in English, both written and verbal
3 -5 years of relevant work experience to include Validation support and execution.
Good problem-solving skills and a proactive approach
Strong communication and interpersonal skills
Good time management skills and maintain the highest standards of quality work
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.
Strong analytical skills and attention to detail.
Ability to prioritize work