QC Scheduler

Job Description
About the role:

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, LabWare 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 overrides where business need or operational reality requires changes to priority, analyst assignment, instrument assignment, equipment downtime, capacity constraints, or other scheduling parameters.

Support quality systems and compliance-related scheduling impacts by incorporating known constraints from SOP revisions, deviations, investigations, change controls, validation activities, method transfer work, equipment changes, and inspection or regulatory support commitments.

Maintain the interim non-GxP Smartsheet-based scheduling solution, including refreshing manually sourced inputs, coordinating master data updates, managing tool limitations, reconciling sample receipt and execution status against Databricks, and preparing scheduling requirements and lessons learned for future SmartQC, LIMS, or digital scheduling integration.

Drive exception management by identifying schedule conflicts, missed or at-risk turnaround targets, overdue flags, reference standard expiry warnings, independence-rule conflicts, invalid or repeat testing impacts, HPLC injection variability, resource constraints, equipment issues, sample visibility gaps, and expedited or non-routine requests requiring cross-functional escalation.

Review and align with QC labs and cross-functional partners regarding QC scheduling activities, manufacturing schedule impacts, testing priorities, sample readiness, daily sample status updates, capacity constraints, schedule engine alerts, manual overrides, and execution risks.

Communicate QC schedule adjustments, priority changes, and downstream impacts across QC, Manufacturing, Supply Chain, QA, Sample Control, Planning, and other impacted functions.

Highlight QC schedule risks, capacity opportunities, data gaps, master data defects, stale source data, schedule refresh issues, rule or configuration gaps, and improvement actions to ensure awareness and timely decision-making across functions.

Support daily QC operational activities as required, including escalation of schedule conflicts and coordination of near-term execution updates with lab leads.

Support and lead QC scheduling project work as required, including central scheduling process redesign, digital scheduling readiness, Smartsheet or SmartQC transition planning, master data remediation, KPI development, schedule engine configuration, rule and threshold refinement, user acceptance or tool validation support, standard work creation, training, post-launch support, quality system or inspection readiness support, operational excellence, 5S, lean initiatives, and continuous improvement activities that reduce manual scheduling effort and improve cross-lab flow.

Support quality system records as an SME or owner as needed.

Skills and qualifications:
Essential:

High school diploma or equivalent.

At least 3 years of experience in Quality Control, laboratory operations, manufacturing support, or quality operations in a good manufacturing practice environment.

Experience using Excel to track, analyze, reconcile, or maintain scheduling data.

Experience coordinating cross-functional scheduling, planning, or operational readiness activities.

Ability to coordinate priorities and communicate schedule changes with laboratory and manufacturing partners.

Experience managing multiple scheduling priorities and escalating conflicts.

Proficiency with Excel and presentation or document tools.

Desired:

Associate degree or higher.

Comfort using digital and AI-enabled tools to review scheduling data, identify trends, and support data-driven decisions; experience with Databricks, Excel formulas, and comma-separated value file imports and exports is preferred.

Experience with Smartsheet, SmartQC, LabWare LIMS, MODA, Veeva/V8, SAP, dashboards, or other digital lab, manufacturing, scheduling, and data-visibility tools preferred.

Experience in a cGMP manufacturing environment, preferably in the biotech or pharmaceutical industry.

Business, technical, supply chain, laboratory operations, quality control, manufacturing, or engineering background.

Experience translating operational scheduling requirements into master data, user requirements, process maps, assay step templates, priority rules, turnaround time rules, planning horizons, standard work, dashboards, alerts, KPI definitions, or schedule-engine configuration.

Experience supporting operational excellence, 5S, lean, method transfer, method or equipment validation, SOP revisions, deviations, investigations, change controls, or inspection readiness activities.

Experience with SAP, LabWare LIMS, Smartsheet, SmartQC, MODA, Veeva/V8, Databricks, dashboards, or similar systems applied to a complex GMP manufacturing and QC laboratory environment, including awareness of non-GxP scheduling tools and validated GxP source-system boundaries.

You will resolve scheduling, data, and compliance issues with laboratory and cross-functional partners. You will identify risks, elevate conflicts, and improve the scheduling process.

Internal and External Contacts:
The Quality Control Scheduler collaborates and interacts with QC laboratory leadership, lab managers, and SMEs across HPLC, Biochemistry, Cell Biology, Microbiology, Sample Control, Raw Materials, and other applicable QC functions. The role also partners with Manufacturing, Supply Chain, Planning, Warehouse Operations, QA, Quality Systems, Regulatory or inspection support teams, Manufacturing Science, Analytical Development, Engineering, Facilities, Validation, LIMS/GLIMS support, Smartsheet or digital tool support, data/reporting resources, and external project resources during post-launch support or transition periods. Engagement with Global Supply Chain or other external partners may be required when QC scheduling decisions affect product supply, release commitments, validation or development study commitments, commercial and clinical testing, or broader network priorities.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$89,900.00 - $141,240.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations
USA - MA - Lexington - BIO OPS

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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