Analyst II

NKGen Biotech•Santa Ana, CA

About The Position

NKGen Biotech is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment. This role involves executing various types of testing on raw materials, in-process samples, and final products to support GMP manufacturing. The analyst will also be responsible for maintaining laboratory equipment, managing inventory, and ensuring compliance with regulatory standards.

Requirements

Bachelor’s degree in a life science field such as Biology, Chemistry, or Biochemistry.
2–4 years of experience in a GMP-regulated QC laboratory within the biotechnology, pharmaceutical, or cell therapy industry.
Hands-on experience with microbiological techniques, including aseptic technique, environmental monitoring, sterility testing, and microbial culture.
Experience with analytical techniques such as flow cytometry (FACS), ELISA, spectrophotometry, or other laboratory instrumentation.
Knowledge of FDA, GLP, cGMP, ALCOA+ data integrity principles, and laboratory documentation practices.
Demonstrated ability to independently perform routine laboratory testing, identify basic technical issues, and perform first-level troubleshooting.
Strong organizational skills with the ability to manage multiple priorities and meet established timelines.
Proficiency in Microsoft Office (Excel, Word, PowerPoint).
Excellent verbal and written communication skills with the ability to work effectively in cross-functional teams.
Ability to work in a fast-paced, start-up environment with minimal supervision.
Flexibility to work weekends, holidays, overtime, or off-shift hours as business needs require.
Candidates must be authorized to work in the United States and successfully complete a background check.

Nice To Haves

Experience working with LIMS or other laboratory data management systems is preferred.
Experience with statistical software is a plus.

Responsibilities

Execute molecular biology, biochemical, microbiological, and physicochemical testing on raw materials, n-process samples, and final products to support GMP manufacturing.
Perform incoming material inspection and release testing to verify that raw materials meet established quality specifications prior to use.
Perform microbiological testing, including environmental monitoring (ISO 5/7/8), sterility testing (FTM/TSB and automated BacT systems), plate reading, colony counting, and documentation of results.
Operate, maintain, and perform routine verification of laboratory instrumentation and computerized systems (e.g., LIMS) in accordance with GMP requirements.
Maintain laboratory and QC inventory, including monitoring laboratory supplies, reagents, and consumables, and coordinating replenishment as needed.
Follow aseptic techniques and gowning procedures required for work in classified cleanroom environments.
Review, document, and maintain laboratory records in compliance with company SOPs, FDA regulations, GLP, cGMP, and data integrity requirements.
Author, revise, and maintain SOPs, test methods, specifications, and technical documentation to support GMP operations and continuous improvement.
Support batch release, stability studies, investigations, deviations, CAPAs, and change controls as required.
Collaborate with QA, Manufacturing, and other cross-functional teams to resolve quality-related issues and support manufacturing operations.
May perform other duties as assigned. The company reserves the right to add or change duties at any time.