Quality Control Specialist II

The QC Specialist II will perform hands‑on quality control testing to support the manufacturing, release, and stability testing of cell and gene therapy products, viral vectors, and associated raw materials and intermediates. This individual must have prior industry experience in a CGT, viral vector, or advanced therapy medicinal product (ATMP) environment and a strong technical background in cell‑based immunology assays, potency assays, and flow cytometry.

The successful candidate will be responsible for executing laboratory testing in accordance with approved procedures, Good Manufacturing Practices (GMP), and applicable regulatory requirements. The role requires proficiency in laboratory instrumentation, electronic laboratory systems, data analysis software, and accurate documentation within systems such as Veeva Quality Management System (QMS) and Laboratory Information Management System (LIMS).

The QC Specialist II will work cross‑functionally with Manufacturing, Quality Assurance (QA), Analytical Development, and other QC teams to ensure reliable analytical results, timely sample testing, and compliance with established quality standards.

• Execute routine and non‑routine QC testing to support CGT and viral vector manufacturing operations.
• Perform cell‑based immunology assays, including applicable cellular response, activation, cytokine, and immune‑function assays.
• Execute potency assays and functional bioassays for cell therapy products, viral vectors, and other biologics, as applicable.
• Perform flow cytometry testing, including sample preparation, staining, acquisition, gating, compensation, and data interpretation.
• Operate, maintain, and troubleshoot laboratory instruments used for cell‑based assays, potency testing, and flow cytometry.
• Perform testing of in‑process samples, drug substance, drug product, raw materials, and stability samples according to approved specifications and procedures.
• Analyze and interpret analytical data to determine whether results meet established acceptance criteria.
• Maintain laboratory readiness, equipment status, reagent inventory, and appropriate controls for analytical testing.

• Independently execute flow cytometry assays using validated or qualified methods.
• Demonstrate working knowledge of multicolor flow cytometry, antibody panels, viability dyes, controls, compensation, gating strategies, and population analysis.
• Perform cell‑based potency and functional assays relevant to CGT and viral vector products.
• Evaluate assay performance, including controls, assay acceptance criteria, and data quality.
• Identify atypical assay behavior, instrument issues, and potential sources of variability.
• Support assay troubleshooting, method optimization, method qualification, and method validation activities as assigned.

• Perform laboratory activities in compliance with current Good Manufacturing Practices (cGMP), approved SOPs, test methods, specifications, and data integrity requirements.
• Complete contemporaneous and accurate documentation in electronic and paper‑based laboratory records, as applicable.
• Review raw data, calculations, assay controls, and analytical results for accuracy and completeness.
• Initiate and support laboratory investigations, out‑of‑specification (OOS) investigations, out‑of‑trend (OOT) assessments, and deviations.
• Participate in root cause analysis and corrective and preventive action (CAPA) activities.
• Follow applicable data integrity principles, including ALCOA+, and maintain complete, traceable, and attributable records.
• Support internal audits, regulatory inspections, and quality system…