QC Analyst

WuXi AppTec

2d • Onsite

About The Position

Reporting to the QC Microbiology Lead, the QC Analyst will perform routine and non-routine microbiological laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes microbiological testing, environmental monitoring, stability sample handling, equipment operation, and documentation in accordance with GMP, corporate quality standards, and regulatory requirements. The QC Analyst will support both startup and steady-state operations, working closely with the QC Microbiology Lead to ensure timely and accurate completion of QC tasks for product release, stability studies, and validation activities.

Requirements

• 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 <61>, <62>, <85>, <1116>, ICH guidelines, and data integrity principles.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees