Specialist, Integrated Digital Labs

Role Summary

Point of contact for New Product Introductions (NPIs), test method transfers and with BTS for lab improvement projects. Works with the laboratories to evaluate NPI equipment, coordinate test method transfers and implement laboratory software improvements. Analyzes proposed workflow improvements in laboratory systems and understands impact. Able to lead project teams within the laboratory to delegate tasks for team members. Executes test cases, test method gap assessments and participates in the verification/validation of workflow requirements.

Responsibilities

• Responsible for evaluating and leading introduction of new products into the laboratories including assessment of test methods, instrumentation needs, and lab readiness.
• Responsible for leading and driving laboratory improvement projects with the global team. Acts as Lake County QC laboratory representative in meetings to ensure laboratories are implementing projects in the agreed upon timeframe.
• Leads local project teams and able to delegate tasks to laboratory analysts assisting with project implementation.
• Creates and updates relevant procedures as well as training material for new workflows. Coordinates responses from end users to address all communication needs to ensure successful project implementation.
• Able to work with SampleManager and Empower platform to implement efficiencies and prepare laboratories for future testing.
• Able to create and update Empower calculations for new and updated test methods in the Lake County QC laboratories.
• Works in the creation of verification and validation protocols for new Empower calculations. Implementation of protocols to include ability to update relevant documents in quality document system.

Qualifications

• Bachelor’s Degree in Science, Engineering, or applicable discipline.
• 3+ years’ related experience in a regulated or pharmaceutical testing lab environment.
• Experience working in both a team setting and independently. Works independently to complete tactical objectives while able to manage own time effectively.
• Strong oral and written communication skills required. Excellent interpersonal skills preferred.