QC Analyst I

Nucleus Biologics•San Diego, CA

4h•$70,000 - $80,000•Onsite

About The Position

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.

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.
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.

Nice To Haves

Familiarity with statistical process control methods a plus.

Responsibilities

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.
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
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.