Job Description

Reporting to the QC Analytical Lead, the QC Analyst will perform routine and non-routine analytical laboratory activities in support of drug product manufacturing at WuXi STA’s Middletown, DE site. This role includes analytical testing, 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, ensuring timely and accurate completion of QC tasks for product release, stability studies, and validation activities.

Responsibilities

Analytical Testing and Support

• Perform QC analytical testing for drug products, raw materials, packaging components, and stability samples in accordance with approved methods and SOPs.
• Conduct analytical tests such as HPLC, GC, TOC, dissolution, UV-Vis, KF titration, and other relevant techniques.
• Accurately record and report test results in compliance with data integrity principles (ALCOA+).
• Operate, calibrate, and maintain analytical laboratory equipment according to GMP requirements.
• Other QC tasks assigned by analytical lead.

Regulatory Compliance and Documentation

• Follow all cGMP, safety, and quality policies while executing analytical laboratory activities.
• Maintain complete, accurate, and inspection-ready laboratory records.
• Assist in the preparation for client and regulatory audits, providing documentation and responding to inquiries.
• Promptly notify the QC Analytical Lead of any deviations, out-of-specification (OOS) results, or atypical findings.

Qualifications

• Associate or bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
• 1–3 years of QC analytical laboratory experience in a GMP-regulated pharmaceutical or biotechnology environment; internship or co-op experience considered.
• Working knowledge of analytical techniques and instrumentation (HPLC, GC, UV-Vis, TOC, etc.).
• Familiarity with GMP regulations, 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.