Overview

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.

Responsibilities

Microbiological Testing and Support

• 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.

Regulatory Compliance and Documentation

• 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.

Qualifications

• 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.

Preferred Qualifications

• 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.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.