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QC Scheduler

Takeda Pharmaceuticals
Lexington, USA
Full-time
Director
Onsite
USD 89900-141240 yearly
Discovered 2 weeks ago
Quality Control schedulingLaboratory workload and capacity planningGMP readiness and compliance schedulingSmartsheetSAPLabWare LIMS

Full Job Posting

About the role

Reports to the Head of Quality Control Laboratory Services and maintains the central QC schedule for Lexington laboratories.

Provides cross-laboratory visibility into workload, sample demand, assay timing, resource constraints, schedule adherence, turnaround time, capacity, risks, GMP readiness, and testing priorities.

May lead cross-functional project work and serves as business process owner for SmartQC.

Responsibilities

  • Govern the baseline central schedule across six QC laboratories and plan testing for patient demand, release, stability, raw materials, validation, and manufacturing.
  • Coordinate scheduling inputs across HPLC, Biochemistry, Cell Biology, Microbiology, Raw Materials, and Sample Control.
  • Assess method, equipment, reagent, material, analyst, sample-readiness, and operational constraints with QC teams.
  • Report and analyze schedule adherence, turnaround time, backlog, capacity utilization, cycle time, and other performance measures.
  • Coordinate priorities and schedule constraints with Sample Control, Manufacturing, Planning, Warehouse Operations, and QC laboratories.
  • Create scenario plans and respond to manufacturing changes, expedited or repeat testing, equipment downtime, analyst constraints, and sample-readiness changes.
  • Maintain scheduling master data and refresh or reconcile data from SAP, LabWare LIMS, MODA, Veeva/V8, Databricks, and other approved sources.
  • Configure Smartsheet scheduling inputs and review schedules, dashboards, and alerts for risks, overdue work, expiries, conflicts, and review-step flags.
  • Document and communicate manual overrides with laboratory managers and subject-matter experts.
  • Account for quality-system and compliance constraints, including SOP changes, deviations, investigations, change controls, validation, method transfers, equipment changes, and regulatory commitments.

Role requirements

  • Coordinate planning across six QC laboratories and work with QC operations and laboratory subject-matter experts.
  • Understand operational factors affecting schedule feasibility, including execution needs, method and equipment constraints, and reagent or material readiness.
  • Maintain QC scheduling data and coordinate data refreshes from approved laboratory, business, and analytics systems.
  • Maintain Smartsheet settings, review scheduling outputs, and document necessary manual overrides.
  • Incorporate quality-system and compliance constraints into scheduling.

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