Senior Quality Control (QC) Analyst

About Nucleus Biologics

At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations. 

Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability. 

The Senior QC Analyst is responsible for executing quality control activities, including in-house environmental monitoring and water testing, final release and stability testing, and incoming quality inspections. This role ensures compliance with applicable regulations and internal quality standards while supporting laboratory operations, data analysis, and inventory management. The Senior QC Analyst also facilitates outsourced testing and contributes to maintaining an efficient and compliant QC laboratory.

RESPONSIBILITIES:

Quality Control Testing

• Conduct testing of raw materials, in-process samples, and finished products to verify compliance with product specifications and regulatory requirements.
• • FTIR, Raman (Identity Testing)
  • USP compendial released testing (i.e. pH, Osmolality, Density, and Appearance)
• Perform routine microbiological testing, including:
• • Microbial enumeration (bioburden, total viable count)
  • Sterility testing
  • Endotoxin testing (LAL)
  • Identification of microorganisms (e.g., Gram staining, biochemical tests, MALDI-TOF)
• Prepare and coordinate shipment of samples to contract laboratories for external testing.
• Perform cell-based assays to assess product potency and functionality as needed.
• Support development, validation, and transfer of microbiological and functional assays in collaboration with R&D and Manufacturing.
• Investigate and document deviations, out-of-specification (OOS) results, and non-conformances in accordance with established procedures.
• Track and follow up on outsourced test results, ensuring timely review and integration into QC documentation.
• Compile, analyze, and trend microbiological and product quality data.
• Support internal quality metrics reporting and identify process improvement opportunities.

Environmental Monitoring & Water Testing

• Perform and oversee routine environmental monitoring of classified and non-classified areas (air, surface, and personnel).
• Conduct high-purity water testing in accordance with USP <645> and other applicable standards.
• Review, analyze, and trend EM and water testing data to identify adverse trends and continuous improvement opportunities.
• Prepare and present quarterly summary reports of EM and water testing results.

Stability Program Management

• Oversee the stability program, including:
• • Onboarding of new stability studies
  • Generating protocols and schedules
  • Reviewing test results and finalizing stability reports
• Ensure studies are conducted in compliance with internal protocols and regulatory expectations.

Laboratory Operations & Compliance

• Operate, maintain, and calibrate laboratory equipment such as autoclaves, incubators, microscopes, and endotoxin readers.
• Maintain accurate, complete, and compliant documentation of all testing, analyses, and laboratory activities.
• Prepare and review SOPs, test methods, protocols, and reports.