WuXi AppTec · 1 day ago
QC Operation Specialist
Middletown, DE
Full-time
Onsite
Entry, Mid Level
1+ years expWuXi AppTec is seeking a QC Operation Specialist to provide critical operational support to the QC laboratories at their Middletown, DE site. This role involves managing stability programs, ensuring compliance with GMP and regulatory requirements, and supporting both Analytical and Microbiology QC teams.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Oversee day-to-day QC operations support, ensuring smooth coordination between Analytical and Microbiology laboratories
Manage the site stability program, including protocol generation, sample storage, testing coordination, data tracking, and reporting in compliance with ICH Q1A–Q1F guidelines
Direct sample receipt, login, storage, and distribution processes, ensuring traceability, chain-of-custody, and GMP compliance
Oversee control, qualification, and inventory of reference standards, reagents, and consumables
Ensure shared laboratory equipment (balances, refrigerators/freezers, washers, autoclaves, water systems) is maintained, calibrated, and documented according to GMP requirements
Monitor operational KPIs for stability timelines, sample turnaround, and lab service efficiency
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
Ensure all operational support activities comply with GMP, ICH guidelines, corporate quality standards, and data integrity principles (ALCOA+)
Maintain complete, accurate, and inspection-ready documentation for stability programs, sample management, and equipment oversight
Support client and regulatory audits by preparing documentation and serving as a point of contact for QC operations
Identify and escalate deviations, out-of-specification (OOS) events, or atypical findings promptly to the QC Manager
Partner with QC Analytical, QC Microbiology, QA, Manufacturing, Facilities, and Supply Chain to ensure operational workflows align with testing timelines and site readiness
Contribute to investigations, CAPA implementation, and change control related to QC operations
Proactively identify and implement process improvements to increase efficiency, strengthen compliance, and reduce operational risks
Qualification
Required
Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related discipline
1–3 years of experience in a GMP-regulated QC laboratory or operational support role
Strong organizational skills with ability to manage stability programs, equipment oversight, and sample logistics simultaneously
Familiarity with GMP regulations, ICH stability guidelines, and data integrity principles (ALCOA+)
Preferred
Experience with LIMS, Empower, or other electronic laboratory management/documentation systems
Previous experience supporting both Analytical and Microbiology QC areas
Exposure to CDMO or multi-client environments
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
Founder, Chairman and CEO
Recent News
2026-01-03
MarketScreener
2025-12-22
Company data provided by crunchbase