QC Operation Specialist

WuXi AppTec•Middletown, DE

About The Position

We are seeking a QC Operation Specialist with strong LIMS expertise to support the implementation, administration, and ongoing optimization of the Laboratory Information Management System (LIMS) at WuXi STA’s Middletown, DE site. This role will serve as the primary QC system operations liaison, ensuring LIMS workflows align with GMP laboratory operations for both Analytical and Microbiology teams. The specialist will support system configuration, master data governance, user management, integration coordination, validation activities, and continuous improvement of electronic laboratory processes. This position will be critical during drug product manufacturing site startup, ensuring compliant, efficient, and inspection-ready electronic data management.

Requirements

Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related scientific discipline.
Minimum 3-5 years of experience working with LIMS in a cGMP QC laboratory setting, including workflow configuration or administration support.
Experience supporting lab startup or expansion activities preferred.
Familiarity with GMP regulations, ICH stability guidelines, and data integrity principles (ALCOA+)

Nice To Haves

Experience with LabX, Empower, and other electronic laboratory management/documentation systems.
Previous experience supporting both Analytical and Microbiology QC areas.
Exposure to CDMO or multi-client environments.
Experience in a GMP-regulated QC laboratory as the operational support role.
Strong organizational skills with ability to manage lab software programs, equipment oversight, and sample logistics simultaneously.

Responsibilities

Support day-to-day QC laboratory operations including sample receipt, scheduling, test coordination, documentation tracking, and release workflow management.
Manage sample lifecycle activities within LIMS, ensuring accurate login, test assignment, result entry, review, approval, and final disposition.
Maintain LIMS master data including products, specifications, test methods, stability protocols, and sampling plans to ensure alignment with current procedures and regulatory requirements.
Configure and maintain electronic workflows to support Analytical, Stability, and Microbiology testing programs.
Generate and maintain electronic Certificates of Analysis (CoA) and QC release reports.
Monitor laboratory turnaround time, backlog, and workload distribution using LIMS reporting tools.
Provide first-level troubleshooting and user support for LIMS-related operational issues.
Identify opportunities to improve laboratory efficiency through workflow optimization and system enhancements.
Develop and maintain SOPs and work instructions related to QC operations and LIMS usage.
Recruit, train, and mentor QC operations staff, ensuring technical competency and adherence to GMP standards.
Foster a culture of efficiency, quality, and continuous improvement within the QC Operations team.
Other QC support tasks assigned by QC analytical lead
Support integration between LIMS and external systems such as Empower (instrument data import) and SAP (sample creation and batch disposition where applicable).
Review and reconcile electronic data to ensure accuracy, traceability, and compliance with ALCOA+ principles.
Coordinate with IT and system vendors to resolve interface issues and maintain system performance.
Participate in periodic audit trail review and user access management to ensure compliance with internal controls.’
Ensure QC operational processes and LIMS configuration comply with GMP regulations and 21 CFR Part 11 requirements.
Support Computer System Validation (CSV) activities including participation in user requirement definition, testing, and documentation review.
Maintain inspection-ready documentation related to QC workflows and electronic systems.
Support internal audits, client audits, and regulatory inspections related to QC operations and electronic data management.
Assist in investigations related to OOS results, deviations, and data integrity findings involving laboratory systems.