QC Specialist (2nd and 3rd Shift) in Princeton, New Jersey at MADE Scientific Inc

About Made Scientific

Made Scientific is a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, testing, and release of autologous and allogeneic cell therapy products for clinical and commercial supply. Headquartered in Princeton, New Jersey, we combine deep scientific expertise with agile, client-focused execution to deliver reliable and scalable manufacturing solutions. Backed by GC Corporation, a global leader in the pharmaceutical and biotechnology industries, Made Scientific is committed to advancing innovative therapies that improve patient lives.

Position Summary

The QC Specialist II supports in-process and release testing for Cell and Gene Therapy (CGT) products. The QC Specialist II will also contribute to stability studies, microbiology, analytical, and reagent testing, delivering high-quality, on-time results to meet manufacturing demands.

Key Responsibilities

Perform analytical and microbiological testing of CGT (Cell and Gene Therapy) products, including Sterility, Mycoplasma, Endotoxin, Flow Cytometry, Cell Count, Potency, and other testing in a controlled cGMP environment.Serve as lead trainer and subject matter expert on analytical methods, including Flow cytometry, PCR and ELISAs, Sterility, Environmental Monitoring, while mentoring junior staff.Coordinate GMP QC lab operations and inventory, ensuring compliance with company policies and applicable requirements.Troubleshoot and resolve issues impacting laboratory operations, test methods, equipment, or facility systems.Coordinate method transfers and validation of methods, utilities and equipment as applicable to ensure regulatory compliance.Review records for in-process monitoring, product release, and stability testing, ensuring adherence to GMP and applicable standards and procedures.Manage Quality System records (CAPA, Change Control, Deviations, LIR) and lead investigations of OOS results, proposing corrective actions.Oversee and execute environmental and method trending, QMR presentations, and Environmental Monitoring Testing in Grade A-D/ISO 5-7 areas.Implement, qualify, and optimize pharmacopoeia methods to enhance processes and ensure regulatory compliance.Create, review, and approve QC documents (SOPs, work instructions, testing methods) to ensure continuous improvement.Support new product and technology introductions, managing cross-functional coordination and prioritization.Update management on progress, roadblocks, and needs to ensure smooth project execution.Perform other duties as assigned to support department goals.