QC Operation Specialist

We are seeking a QC Operation Specialist to provide critical operational support to the QC laboratories at WuXi STA’s Middletown, DE site. This role is responsible for stability room and equipment management, sample logistics, and controlled documentation, ensuring QC laboratories operate efficiently, meet testing timelines, and remain in full compliance with GMP and regulatory requirements. The QC Operation Specialist will be a key contributor during both startup and steady-state operations, supporting Analytical and Microbiology QC teams.

Responsibilities

Stability Sample Management and Laboratory Operations Support

• 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.
• Other QC support tasks assigned by QC analytical lead
  
  

Regulatory Compliance and Documentation

• 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.
  
  

Cross-Functional Collaboration & Continuous Improvement

• 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.
  
  

Qualifications

• 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 Qualifications

• 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.
  
  

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.