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. 

About the role

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.

What you'll do:

Environmental Monitoring & Water Testing:

• Perform in-house environmental monitoring of classified and non-classified areas, including air, surface, and personnel monitoring.
• Conduct high-purity water testing in accordance with USP <645> and other applicable standards.
• Maintain and document environmental and water testing results, ensuring compliance with internal procedures and regulatory expectations.

QC Testing & Product Release:

• Perform QC final release testing for raw materials, in-process, and finished goods per established specifications.
• Execute stability testing and support stability studies by collecting, testing, and documenting data.
• Perform cell-based assays to assess product potency and functionality as required.
• Support functional assay development and validation in collaboration with R&D and manufacturing teams.
• Ensure timely review and approval of test results, escalating deviations or out-of-specifications (OOS) as necessary.

Incoming Quality Inspection:

• Conduct visual and physical inspections of incoming raw materials, components, and packaging to ensure compliance with approved specifications.
• Maintain accurate documentation of inspection results, release decisions, and nonconformance findings.

Sample Management & Outsourced Testing:

• Prepare, package, and coordinate the shipment of samples for external contract laboratory testing.
• Track outsourced test results and ensure timely follow-up for reporting and data review.

Data Analysis & Trending:

• Compile, analyze, and trend QC test data to identify potential quality issues, process improvements, or trends requiring further investigation.
• Generate reports and present findings to support quality metrics and continuous improvement initiatives.

Laboratory Maintenance & Inventory Management:

• Maintain QC laboratory supplies and reagents at optimal inventory levels, ensuring uninterrupted operations.
• Oversee cleaning and general upkeep of the QC laboratory, ensuring compliance with Good Laboratory Practices (GLP) and regulatory requirements.
• Support routine calibration, qualification, and maintenance of laboratory equipment.

Qualifications:

Requirements

• Bachelor’s degree in Chemistry, Microbiology, Biology, or a related field. A combination of education and/or relevant job experience may be considered.
• 3-5 years of