WuXi AppTec · 19 hours ago
QC Operation Specialist
Middletown, DE
Full-time
Onsite
Mid Level
3+ years expWuXi AppTec is seeking a QC Operation Specialist with strong LIMS expertise to support the implementation and optimization of their Laboratory Information Management System at the Middletown, DE site. The role involves managing QC laboratory operations, ensuring compliance with GMP regulations, and optimizing electronic data management processes.
BiotechnologyMedical DeviceHealthcareOutsourcingPharmaceuticalHealth Care
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
Qualification
Required
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
Preferred
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
Familiarity with GMP regulations, ICH stability guidelines, and data integrity principles (ALCOA+)
Company
WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical.
10001+ employees
H1B Sponsorship
WuXi AppTec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (5)
2021 (1)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.59BKey Investors
Eight Roads Ventures
2025-03-03Acquired
2018-05-08IPO
2016-03-06Debt Financing· $1.5B
Leadership Team
Ge Li
CEO
Recent News
South China Morning Post
2026-01-23
Morningstar.com
2026-01-19
2026-01-15
Company data provided by crunchbase