The Role:

The Specialist I, QC Planner & Scheduler is an individual contributor role for cross-functional teams with the goal to improve productivity and effectively achieve core business activities for routine testing and analytical method transfer.

Here’s What You’ll Do:

Planner / Scheduler Routine Testing and Project Delivery:

• Coordinate with internal stakeholders to negotiate, prioritize and schedule routine, non-routine, and project work in QC to achieve business objectives
• Coordinate and own the lab testing schedule based on production schedules, analyst schedules and equipment availability
• Track testing completion for delivery of CoAs on time for batch disposition
• Ensure equipment is maintained in coordination with analyst schedules, Facilities & Engineering and Vendor availability
• Provide status and progress monitoring for QC owned Quality Event records to ensure timely completion and escalation.
• Track and lead Continuous Improvement projects within QC, including lean lab initiatives
• Provide routine updates to QC Management, Site Leadership Team and Project Teams
• Influence teams and organization to streamline site operational readiness and routine testing processes
• Track and report metrics for the QC Organization
• Take initiative to improve lab operations, ways of working, and lead by example and build collaborative relationships

Requirements:

• Bachelor’s degree in a relevant science related field is required (life sciences)
• 3+ years previous GXP QC Laboratory experience

Additional Preferences:

• Trained in Lean/Six-sigma Methodologies or interest in pursuing Lean certifications
• Trained in Project Management methodologies or interest in pursuing Project Management certifications
• Demonstrated strong self-management skills
• Demonstrated group facilitation and project management skills
• Good written and oral communication skills including effective presentation skills
• Good interpersonal skills
• Desire to solve complex problems with use of software tracking tools
• Ability to influence cross functionally and across different levels of the organization
• Knowledge of safety and GMP requirements
• Experience in a manufacturing environment
• Educational background in science
• Experience in regulatory inspections.
• Ability to think strategically and to influence others.
• Ability to identify, prioritize, and implement actions to continuously improve operations and systems and manage risks.
• Experience in electronic LIMS, Lab Scheduling tools, Project Management software, Enterprise Management systems, Quality Management Systems, Document Management Systems.