Job Summary: 

The QC Scheduler/Planner is responsible for coordinating and optimizing Quality Control laboratory activities to ensure timely testing and release of raw materials, intermediates, finished goods, and stability samples. This role serves as the central planning function for QC operations, aligning laboratory capacity (analysts and instrumentation) with production schedules and regulatory requirements. The position requires strong organizational, analytical, and cross-functional coordination skills to manage sample flow, testing priorities, and standard lifecycle management in a GMP-regulated environment.

Job Responsibilities:

Sample & Workflow Coordination

• Track and manage all samples entering the QC laboratory, including raw materials, in-process/intermediate, finished goods, and stability samples.
• Ensure accurate logging, prioritization, and visibility of sample status from receipt through testing completion.
• Coordinate with Manufacturing, Supply Chain, and Warehouse teams to align sample submissions with production and release timelines.

QC Testing Scheduling & Planning

• Develop and maintain detailed testing schedules (daily, weekly, and longer-term forecasts).
• Assign testing activities based on analyst qualifications, availability, and workload balancing.
• Coordinate usage of laboratory instruments to maximize efficiency and throughput.
• Adjust schedules dynamically to accommodate priority changes, deviations, or operational constraints.

Cycle Time & Performance Tracking

• Monitor end-to-end testing cycle times across all sample types.
• Track key performance indicators (KPIs), including turnaround time, on-time testing, and release performance.
• Identify delays, bottlenecks, and inefficiencies within laboratory workflows.
• Provide data-driven insights and reporting to QC and Quality leadership.

Instrument & Capacity Management

• Monitor laboratory instrument capacity and utilization.
• Coordinate instrument availability, including preventive maintenance, calibration, and downtime planning.
• Support capacity planning efforts to align testing demand with available lab resources.

Standards & Reference Material Management

• Coordinate the planning, availability, and lifecycle of analytical standards and reference materials.
• Track inventory levels, usage rates, expiration dates, and requalification requirements.
• Ensure standards are available and aligned with testing schedules and production release needs.
• Prevent testing delays due to expired or unavailable standards.

Cross-Functional Coordination

• Serve as the central coordination point between QC, Manufacturing, Supply Chain, and Quality Assurance.
• Communicate testing priorities, schedule updates, and risks impacting release timelines.
• Support escalation and resolution of critical testing delays or resource conflicts.

Compliance & Documentation

• Ensure scheduling and tracking activities comply with GMP and regulatory requirements.
• Maintain accurate, audit-ready records for sample tracking, testing schedules, and standards usage.
• Support internal audits, regulatory inspections, and client audits as needed.

Other Responsibilities

• Support continuous improvement initiatives related to QC efficiency and throughput.
• Participate in implementation or optimization of laboratory planning systems and digital tools.
• Perform additional duties as assigned by QC or Quality leadership.

Education and Experience

• Bachelor’s degree in science, engineering, supply chain, or related field.
• Experience in pharmaceutical, biotechnology, or regulated laboratory environments preferred.
• Experience in QC operations, laboratory scheduling, or production/material planning strongly preferred.
• Familiarity with GMP regulations and laboratory workflows.

Knowledge, Skills, and Abilities

• Strong planning and scheduling skills with the ability to manage multiple priorities.
• Understanding of QC laboratory operations, analytical testing workflows, and dependencies.
• Ability to analyze data and generate performance metrics and reports.
• Strong organizational skills with high attention to detail and accuracy.
• Effective communication and cross-functional coordination abilities.
• Problem-solving mindset with the ability to quickly adapt to changing priorities.
• Proficiency with scheduling tools, LIMS, ERP systems, or data analysis tools (preferred).
• Ability to manage multiple priorities in a fast-paced, compliance-driven environment.