QC Analyst I

company

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.

role

JOB SUMMARY:

Nucleus Biologics™, The Cell Performance Company™, is the leading provider of custom cell-growth media, tools, and technologies for cell and gene therapy. Our mission is to speed the time from scientific discovery to cure by delivering innovative, transparent and cGMP products and services with the goal of disrupting the market and eliminating antiquated practices and products. We have multiple state-of-the-art facilities where we manufacture our products.

The QC Analyst I is responsible for executing routine quality control activities, including in-house environmental monitoring (static and dynamic) and water testing, in-process quality monitoring during manufacturing events and incoming quality inspections. This role ensures compliance with applicable regulations and internal quality standards while supporting laboratory operations, data entry and trending, and inventory management. The QC Analyst I will also contribute to maintaining an efficient and compliant QC laboratory through the execution of daily and weekly tasks.

RESPONSIBILITIES:

Environmental Monitoring & Water Testing

- Perform routine environmental monitoring of classified and non-classified areas (air, surface, and personnel).
- Perform personnel and environment monitoring during manufacturing runs.
- Conduct high-purity water testing in accordance with USP <645> and other applicable standards.

Quality Control Testing

- Conduct testing of raw materials, in-process samples, and finished products to verify compliance with product specifications and regulatory requirements. Testing may include:
- FTIR, Raman (Identity Testing); training provided
- USP compendial released testing (i.e. pH, Osmolality, Density, and Appearance)

- Support investigations of deviations, out-of-specification (OOS) results, and non-conformances, including documenting findings in accordance with established procedures.
- Support internal quality metrics reporting and participate in process improvement activities.
- Complete, archive and maintain raw material specification packets

Laboratory Operations & Compliance

- May operate and/or assist with maintaining laboratory equipment such as autoclaves, incubators, microscopes, and endotoxin readers.
- Maintain accurate, complete, and compliant documentation of all QC activities, testing, analyses, and laboratory activities.
- May assist with preparing and reviewing SOPs, test methods, protocols, and reports.
- Support internal and external audits and follow laboratory practices aligned with cGMP and ISO 9001/13485 requirements.
- Assist with maintaining optimal inventory levels of reagents, media, and consumables.
- Ensure cleanliness, organization, and operational readiness of the QC laboratory.
- Support qualification and preventive maintenance activities for lab equipment.

REQUIREMENTS:

- Bachelor’s degree in Chemistry, Microbiology, Biology, or a related field is preferred. A combination of education and/or relevant job experience may be considered.
- 1-3 years of experience in a QC laboratory within the pharmaceutical, biotechnology, or related regulated industry. Relevant cGMP laboratory internships may be considered.
- Cleanroom and gowning experience in ISO Class 7/8 areas required
- Experience with environmental/personnel monitoring, water testing, or microbiological/chemical testing methodologies preferred; training provided.
- Familiarity with USP and cGMP requirements; exposure to ISO 9001/13485 a plus.
- Strong organizational skills with attention to detail and the ability to manage multiple tasks.
- Proficiency in Microsoft Excel for data entry and basic trending; experience with LIMS or similar QC systems a plus.
- Excellent communication and documentation skills, with the ability to work cross-functionally in a fast-paced environment.

ADDITIONAL SKILLS:

·          Ability to prioritize daily and weekly tasks and meet assigned deadlines

·          Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships

·          Strong attention to detail and process mindset

·          Ability to follow established procedures and escalate issues appropriately

·          Excellent verbal and written communication skills.

·          Familiarity with statistical process control methods a plus.

PHYSICAL REQUIREMENTS:

·          Ability to hear and speak to employees and external associates on the phone and in person.

·          Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)

·          Ability to wear full cleanroom gowning in accordance with ISO 7 and 8 requirements

·          Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions

TRAVEL REQUIREMENTS:

·          None

NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.