WuXi AppTec · 6 hours ago
QC Analyst
Middletown, DE
Full-time
Onsite
Entry Level
1+ years expWuXi AppTec is a company that supports drug product manufacturing, and they are seeking a QC Analyst to perform microbiological laboratory activities. The role involves microbiological testing, environmental monitoring, and ensuring compliance with regulatory requirements in a GMP environment.
BiotechnologyHealth CareMedical DeviceOutsourcingPharmaceutical
Responsibilities
Perform microbial QC testing for drug products, raw materials, packaging components, and utilities in accordance with approved methods and SOPs
Conduct tests such as environmental monitoring, bioburden, endotoxin, microbial limits, and microbial identification
Accurately record and report test results in compliance with data integrity principles (ALCOA+)
Operate, calibrate, and maintain microbiology laboratory equipment according to GMP requirements
Other QC tasks assigned by microbiology lead
Follow all cGMP, safety, and quality policies while executing microbiology laboratory activities
Maintain complete, accurate, and inspection-ready microbiology laboratory records
Assist in the preparation for client and regulatory audits, providing documentation and responding to inquiries
Promptly notify the QC Microbiology Lead of any deviations, out-of-specification (OOS) results, or atypical findings
Qualification
Required
Associate or bachelor's degree in Microbiology, Biology, or related scientific discipline
1–3 years of QC microbiology experience in a GMP-regulated pharmaceutical or biotechnology environment; internship or co-op experience considered
Working knowledge of microbiological techniques and instrumentation
Familiarity with GMP regulations, USP, ICH guidelines, and data integrity principles
Preferred
Experience with LIMS, Empower, or other electronic laboratory systems
Previous work in a CDMO or multi-client environment
Ability to work flexibly across analytical and microbiological testing areas as cross-trained
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
MarketScreener
2025-12-22
South China Morning Post
2025-12-19
Company data provided by crunchbase