QC Scheduler
Job in
Lexington, Middlesex County, Massachusetts, 02173, USA
Listed on 2026-10-12
Listing for:
Takeda
Full Time
position Listed on 2026-10-12
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Production QC/QA
Job Description & How to Apply Below
As the QC Scheduler you will report to the Head of Quality Control Laboratory Services and maintain the central Quality Control schedule for Lexington laboratories. You may lead cross-functional project work. This role serves as the QC-focused central scheduler for the future Quality Control (QC) scheduling process, providing cross-laboratory visibility to QC workload, sample demand, assay timing, analyst and instrument constraints, schedule adherence, turnaround-time performance, capacity utilization, execution risks, GMP readiness impacts, and testing priorities.
You will also act as a business process owner for the SmartQC system.
- Develop, maintain, and govern the central QC schedule as the site’s central schedule for baseline planning across the six functional QC laboratories in scope.
- Plan and schedule Quality Control testing to support patient demand, product release, stability, raw materials, validation, manufacturing, and changing business priorities.
- Coordinate QC schedule inputs across the six functional laboratories in scope HPLC, Biochemistry, Cell Biology, Microbiology, Raw Materials, and Sample Control, recognizing that implementation depth may vary by lab depending on upstream process readiness and feasible planning horizon.
- Partner with QC operations and laboratory subject‑matter experts (SMEs) to understand testing execution needs, method or equipment constraints, reagent and material readiness, lab housekeeping or readiness impacts, and other operational factors that may affect schedule feasibility.
- Report QC scheduling metrics for schedule adherence, turnaround time adherence, turnaround time risk, backlog, capacity utilization, cycle‑time assumptions, process performance, and continuous improvement opportunities at the individual lab and collective cross‑lab levels.
- Use QC data review, data trending, backlog, schedule adherence, and testing‑cycle information to identify risks, support operational excellence, and recommend improvements to schedule assumptions, standard work, and cross‑lab flow.
- Coordinate with Sample Control, Manufacturing, Planning, Warehouse Operations, and QC labs to confirm sample availability, priority changes, readiness gaps, and testing constraints that could affect the central QC schedule.
- Translate manufacturing demand, release needs, stability pulls, raw material requirements, and non‑routine requests into QC schedule assumptions, testing priorities, and scenario plans.
- Respond to and support QC schedule change requirements and scenario planning, including manufacturing schedule changes, expedited testing, invalid or repeat testing, equipment downtime, analyst constraints, and sample readiness shifts.
- Maintain QC scheduling master data, including product, testing, resource, priority, and turnaround‑time information.
- Coordinate scheduled data refreshes by querying or obtaining exports from SAP, Lab Ware LIMS, MODA, Veeva/V8, Databricks, and other approved sources, then uploading or reconciling data into the Smartsheet scheduling engine.
- Maintain manual Smartsheet configuration inputs, including analyst qualification, analyst availability, equipment assignment, recurring task lists, controls re‑evaluation, assay step templates, cycle‑time, test prerequisites, priority rules, turnaround time rules, planning horizons, thresholds, and related scheduling settings.
- Review scheduling engine outputs, including per‑lab schedule sheets, schedule boards, unified cross‑lab schedule reports, KPI dashboards, and alerts for turnaround time at‑risk items, overdue work, reference standard expiry, scheduling conflicts, and review‑step independence flags.
- Work with lab managers and SMEs to apply, document, and communicate manual…
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