QC Laboratory Operations Lead

Overview

The QC Laboratory Operations Lead is responsible for managing core Quality Control support functions at WuXi STA's drug product manufacturing facility in Middletown, DE. This role provides leadership and oversight for Stability Program Management, Sample Lifecycle Management, Metrology and Laboratory Equipment Lifecycle Management, Inventory and Consumable Control Management, and critical laboratory electronic systems, like Empower and LIMS. The position ensures laboratory operations are adequately resourced, compliant with current GMP requirements, inspection-ready, and capable of supporting manufacturing, product release, and stability commitments. The QC Laboratory Operations Lead collaborates closely with QC Analytical, QC Microbiology, Manufacturing, Quality Assurance, Validation, Engineering, and Information Technology to ensure effective laboratory operations and continuous improvement.

 

 

Responsibilities

Stability Program Management

• Own and manage the site stability program, including study initiation, sample pulls, scheduling, storage, inventory tracking, and sample reconciliation.
• Ensure stability studies are executed in accordance with approved protocols, regulatory requirements, and client commitments.
• Coordinate stability chamber utilization, monitoring, qualification activities, and capacity planning.
• Maintain stability databases and ensure accurate tracking of all stability samples throughout the study lifecycle.
• Monitor program performance and ensure timely communication of upcoming testing requirements.

Sample Lifecycle Management

• Lead laboratory sample management operations from receipt through storage, distribution throughout the testing groups, reconciliation, retention, and disposal.
• Develop and/or maintain procedures governing sample custody, chain of custody documentation, and sample traceability.
• Manage sample logistics supporting release testing, stability testing, investigations, validation activities, and client requests.
• Ensure sample inventory systems are maintained accurately and support efficient laboratory workflows.
• Identify and implement improvements to sample handling processes that enhance compliance and operational efficiency.

Metrology and Equipment Lifecycle Management

• Oversee the full lifecycle management of laboratory equipment, including procurement, commissioning, qualification, calibration, preventive maintenance, repair, and retirement.
• Manage equipment scheduling to ensure continuous laboratory readiness and minimize downtime.
• Partner with Validation, Engineering, and vendors to support instrument qualification and maintenance activities.
• Ensure calibration and maintenance programs are executed within established due dates.
• Monitor equipment performance metrics and drive continuous improvement initiatives.
• Monitor vendor performance metrics and implement contingency plans where necessary to ensure there is no disruption to throughput.
• Maintain equipment inventory records and ensure compliance with applicable GMP requirements.

Inventory and Consumable Management

• Establish and manage laboratory inventory programs for reagents, consumables, reference standards, columns, and critical supplies.
• Monitor inventory levels and implement forecasting processes to ensure uninterrupted laboratory operations.
• Coordinate purchasing activities and maintain appropriate stock levels while minimizing waste and expired materials.
• Ensure materials are received, stored, qualified, and utilized according to approved procedures.
• Develop key performance metrics related to inventory utilization, availability, and cost management.
• Lead small team of dedicated contractors supporting consumable materials.

Laboratory Electronic System Oversight

• Serve as business owner or system administrator for critical laboratory computerized systems, including LIMS, CDS, Electronic Laboratory Notebooks, and related GMP applications.
• Coordinate system access management, user administration, configuration changes, periodic reviews, and data integrity activities.
• Partner with IT, Quality Assurance, and system vendors to maintain system compliance and operational effectiveness.
• Support computer system validation activities and change control processes.
• Ensure regulatory compliance with data integrity requirements and maintain inspection readiness for all laboratory systems.

Compliance and Quality Systems

• Ensure laboratory operational processes comply with FDA, EMA, ICH, and applic