Quality Control Specialist II

Position Summary:

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.

Responsibility:

QC Laboratory Testing and Analytical Assays

• 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.

Flow Cytometry and Cell‑Based Assay Expertise

• 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.

GMP Documentation and Quality Compliance

• 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 activities as required.

Electronic Systems and Instrument Data Analysis

• Utilize Veeva Vault QMS or equivalent electronic quality management systems to support deviations, CAPAs, change controls, controlled documents, and related quality records.
• Use LIMS to manage sample login, sample tracking, test assignments, results entry, and laboratory workflow documentation.
• Operate CGT laboratory instrumentation and associated acquisition and analysis software.
• Analyze flow cytometry data using software such as FlowJo, FACSDiva, CytExpert, or equivalent platforms, depending on the laboratory instrumentation.
• Use instrument‑specific software for cell analysis, viability, cell counting, potency testing, and other relevant analytical methods.
• Review electronic raw data, audit trails, instrument‑generated reports, and analytical calculations in accordance with approved procedures.
• Maintain compliance with applicable electronic records and electronic signature requirements.

Equipment, Laboratory Operations, and Continuous Improvement

• Perform routine instrument checks, calibration verification, maintenance, and troubleshooting within the scope of training and authorization.
• Ensure instruments and laboratory equipment remain in a qualified or calibrated state before use.
• Support laboratory investigations related to instrument performance, assay failures, and unexpected analytical results.
• Assist with implementation and transfer of analytical methods from Analytical Development into QC.
• Identify opportunities to improve laboratory efficiency, data quality, assay robustness, and testing turnaround times.
• Collaborate with cross‑functional teams to support manufacturing schedules, batch disposition timelines, and product quality objectives.

Required Qualifications

• Bachelor’s degree in biology, Cell Biology, Immunology, Biotechnology, Biochemistry, Molecular Biology, Biomedical Sciences, or a related life science discipline.
• Minimum of 5 years of relevant industry experience, including direct hands‑on experience in cell and gene therapy, viral vector manufacturing, or a closely related GMP biologics environment.
• Demonstrated hands‑on experience executing cell‑based immunology assays, potency assays, and flow cytometry.
• Experience working in a regulated GMP laboratory environment.
• Proficiency with laboratory instrument software and analytical data review.
• Working knowledge of LIMS and electronic quality management systems such as Veeva Vault QMS.
• Strong understanding of laboratory documentation, data integrity, assay controls, and acceptance criteria.
• Ability to troubleshoot assays, interpret analytical results, and recognize atypical or unexpected data.
• Strong attention to detail, organizational skills, and ability to manage multiple testing priorities in a fast‑paced manufacturing environment.
• Effective written and verbal communication skills and the ability to work independently and collaboratively.