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:
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Own and manage the site stability program, including study initiation, sample pulls, scheduling, storage, inventory tracking, and sample reconciliation.
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Ensure stability studies are executed in accordance with approved protocols, regulatory requirements, and client commitments.
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Coordinate stability chamber utilization, monitoring, qualification activities, and capacity planning.
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Maintain stability databases and ensure accurate tracking of all stability samples throughout the study lifecycle.
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Monitor program performance and ensure timely communication of upcoming testing requirements.
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Lead laboratory sample management operations from receipt through storage, distribution throughout the testing groups, reconciliation, retention, and disposal.
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Develop and/or maintain procedures governing sample custody, chain of custody documentation, and sample traceability.
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Manage sample logistics supporting release testing, stability testing, investigations, validation activities, and client requests.
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Ensure sample inventory systems are maintained accurately and support efficient laboratory workflows.
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Identify and implement improvements to sample handling processes that enhance compliance and operational efficiency.
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Oversee the full lifecycle management of laboratory equipment, including procurement, commissioning, qualification, calibration, preventive maintenance, repair, and retirement.
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Manage equipment scheduling to ensure continuous laboratory readiness and minimize downtime.
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Partner with Validation, Engineering, and vendors to support instrument qualification and maintenance activities.
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Ensure calibration and maintenance programs are executed within established due dates.
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Monitor equipment performance metrics and drive continuous improvement initiatives.
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Monitor vendor performance metrics and implement contingency plans where necessary to ensure there is no disruption to throughput.
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Maintain equipment inventory records and ensure compliance with applicable GMP requirements.
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Establish and manage laboratory inventory programs for reagents, consumables, reference standards, columns, and critical supplies.
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Monitor inventory levels and implement forecasting processes to ensure uninterrupted laboratory operations.
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Coordinate purchasing activities and maintain appropriate stock levels while minimizing waste and expired materials.
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Ensure materials are received, stored, qualified, and utilized according to approved procedures.
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Develop key performance metrics related to inventory utilization, availability, and cost management.
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Lead small team of dedicated contractors supporting consumable materials.
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Serve as business owner or system administrator for critical laboratory computerized systems, including LIMS, CDS, Electronic Laboratory Notebooks, and related GMP applications.
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Coordinate system access management, user administration, configuration changes, periodic reviews, and data integrity activities.
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Partner with IT, Quality Assurance, and system vendors to maintain system compliance and operational effectiveness.
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Support computer system validation activities and change control processes.
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Ensure regulatory compliance with data integrity requirements and maintain inspection readiness for all laboratory systems.
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Ensure laboratory operational processes comply with FDA, EMA, ICH, and applicable GMP regulations.
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Support investigations, deviations, CAPAs, change controls, and risk assessments associated with laboratory operations.
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Participate in internal audits, client audits, and regulatory inspections.
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Monitor compliance trends and implement preventive actions to reduce operational risk.
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Drive continuous improvement initiatives to improve efficiency, compliance, and employee engagement.
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Build, develop, and lead the Laboratory Operations team.
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Provide coaching, mentoring, training and career development opportunities for team members.
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Establish performance expectations and conduct routine performance evaluations.
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Manage staffing, resource allocation, and succession planning.
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Foster a culture focused on compliance, operational excellence, accountability, and continuous improvement.
Qualifications:
Required Qualifications:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related scientific discipline required; advanced degree preferred.
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Minimum 7 years of GMP pharmaceutical laboratory experience with at least 3 years in leadership or supervisory roles.
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Demonstrated experience managing laboratory operations, stability programs, sample management, metrology, equipment programs, or laboratory systems.
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Strong understanding of GMP regulations, data integrity principles (ALCOA+), and regulatory inspection expectations.
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Experience with LIMS, CDS, stability management software, inventory systems, and computerized system compliance.
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Proven ability to manage multiple priorities in a fast-paced pharmaceutical manufacturing environment.
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Strong organizational, communication, project management, and leadership skills.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
