Quality Control Testing Scheduler

Legend Biotech is seeking an Quality Control Testing Scheduler as part of the Quality team based in Raritan, NJ. 

Role Overview

We are seeking a detail – oriented and highly organized QC Testing Scheduler to join our team for Quality Control. The ideal candidate will manage and maintain our automated scheduling system, ensuring that all tasks and assignments are executed on time and without errors. This role requires strong organizational skills, problem-solving skills, technical knowledge, and the ability to work in a fast-paced GMP environment.

Key Responsibilities  

• Testing Scheduling Management: Configure, monitor, and maintain job scheduling systems (e.g Smart QC, BINOC)
  
• Automation: Design and implement automated testing scheduling workflows to optimize system performance and efficiency alongside with analysts’ tasks and time
  
• Monitoring: Monitor test execution, adjust schedule as needed to address tests failures.
  
• Documentation: Maintain detailed documentation of tests schedules, procedures, and any changes made to the schedule
  
• Collaboration: Work closely with other analysts, senior analysts, supervisors, and management to ensure that testing schedules align with organizational needs.
  
• Reporting: Generate reports on test performance, including success rates, failures, run, and delay times
• Change Management: Participate in change management processes to ensure that all routine testing scheduling changes are properly vetted and documented.
  
• Continuous Improvement: Identify opportunities for process improvement in scheduling and workflow automation that allows workload to be evenly distributed amongst all analysts.
  
• Audit support: Ensure Good Documentation Practices and lab readiness are upheld for potential support of regulatory agency audits.
  
• Downtime tasks: Includes the following but not limited to: assist with lab cleanings, logbook review, request of logbooks, filing training records, assist with lab organization

Requirements

• Bachelor’s degree in science, Engineering or equivalent technical discipline is required.
  
• Minimum of 2-4 year work experience, within a GMP biological and/or pharmaceutical industry is required.
  
• Knowledge of cGMP and GDP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
  
• Detailed knowledge of CAR-T QC test methods and related equipment is preferred.
  
• Excellent written and oral communication skill are required.
  
• Off-hour responses may be required to support business needs.
  
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
  
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
  
• Comfortable with speaking and interacting with inspectors.
• Skills/Competencies:
  
  • Ownership and Commitment
    o Takes responsibility for one's results and deliverables; sets and achieves goals to support organizational priorities.
    o Takes initiative; willing to take unpopular positions/actions when necessary; courageous and assertive.
    o Works effectively in the face of ambiguity, shifting priorities, and rapid change; maintains a positive outlook in difficult situations; a change agent.
  • Agility and Prioritization
    o Identifies and focuses on activities of highest value and impact; makes informed decisions quickly.
    o Results oriented; defines goals, metrics and actionable plans and manages work to deliver desired outcomes; has a sense of urgency.
    o Considers resources, alternatives, constraints and desired outcomes to make effective decisions.
    o Employs good project management principles to appropriately align time, resources, and budgets.
  • Leadership and Responsibility
    o Accurately gauges analysts’ knowledge level and skillset to determine the most effective schedule.
  • Teamwork and Communication
    o Appreciates diverse perspectives and is actively inclusive of others' input and ideas; treats others with respect.
    o Articulates ideas clearly and succinctly in a variety of settings and styles; can get messages across that have the desired effect.
    o Leverages personal credibility and interpersonal skills to help others make better decisions and positively impact outcomes; able to develop/maintain effective working relationships internally and externally.
    o Employs a global mindset in decision-making and errs on the side of over-communicating to create organizational transparency, trust and alignment.
    o Work closely with other analysts, senior analysts, supervisors, and management to ensure that job schedules align with organizational needs.
    o Ability to work independently and as a part of a team
  • Continuous Improvement
    o Takes initiative, actively shares knowledge, builds skills, promotes new ideas and embraces change.
    o Generates new solutions to problems by challenging the status quo and conventional thinking.
    o Identify opportunities for process improvement in scheduling and workflow automation allowing all analyst workload to be similar day to day

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