Quality Control Laboratory Specialist

Key Responsibilities

• Perform automated dPCR, flow cytometry, and other supporting procedures to validate the methods and enable the release testing and stability monitoring of cell therapy products and in-process samples.
• Support technical transfer from Analytical Development, receive analytical method training, pre-qualification tests, and validation executions.
• Act as a subject matter expert in technical discussion, document review, and investigations.
• Prepare departmental SOPs, technical documents, undertake investigations, and draft troubleshooting plans.
• Support quality events (change control, deviations, and CAPA), QC Operations, including LIMS implementation, equipment qualification, maintenance and calibration, and Sample Management.
• Perform other duties as requested by supervisor to support the implementation of automated methods.
• Author and/or review analytical test results, technical and regulatory documents including but not limited to analytical study data summaries and reports, analytical method validation protocols and reports, standard operating procedures (SOP).

Required Qualifications

• Hands-on experience with laboratory automation platforms and automated workflow integration of analytical methods in QC or AD environment.
• Experience supporting automated liquid handlers such as Hamilton, Duet, Tecan, or similar systems.
• Understanding of QC workflows and sample processing operations.
• Experience leading or supporting automation integration and cross-functional technical projects.
• Familiarity with quality systems such as Veeva and working knowledge of cGMP environments, quality events (change control, deviations and CAPA) and data integrity expectations.
• Strong communication, collaboration, and problem-solving skills.

Preferred Qualifications

• Experience in Hamilton and/or other cGMP automatic liquid handling instruments for QC assays.
• Experience in various cell therapy analytical techniques including Flow cytometry, and dPCR.