Laboratory Systems Specialist

About the role

The Laboratory Sciences Systems Specialist is responsible for the validation, administration and management of data acquisition systems within Laboratory Sciences by supporting global validation and implementation, change controls and overall lifecycle management of the systems.

Responsibilities

• Execute GLP Validation processes, including, but not limited to:
  • Required document preparation (e.g., validation plan, traceability matrix, validation report, test script creation and execution)
  • Change control execution
  • Decommissioning of retired systems
  • System updates and releases
• Responsible for drafting standard operating procedures for use and maintenance of the system
• Responsible for supporting system implementation at the site level via collaboration with site stakeholders
• Oversight and management of system lifecycle including system upgrades
• Serve as Global System Administrator for laboratory systems, as assigned
• Perform system analysis and provide insight for improvements
• In conjunction with users and managers, define requirements/user stories, document specifications, implement and support systems
• Identify areas for process improvements and innovation
• Implement and plan for improvements, enhancements, and new applications to systems in collaboration with Global System Owner and Global SMEs.
• Advise on need for system upgrades.
• Interact with a variety of stakeholders including End Users, Management, Business Partners and Vendor

Qualifications

• Education: Bachelor's degree (B.A./B.S.) or equivalent, preferably in a scientific-related discipline.
• Experience: Minimum of three years related experience required within a CRO, Pharma or similar working environment.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Must be able to influence resources/staff without direct reporting relationships.
• Ability to multi-task, excellent written and verbal communication skills, organizational skills, and attention to detail required.
• Must possess analytical thinking and problem-solving skills and be able to prioritize and re-evaluate priorities as situations change.
• Working knowledge of computer software (MS Word, MS Excel and databases) required.
• Exper