Job Summary
NKGen Biotech is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment.
General 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
Job Qualifications & Skills
· 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.
· Experience working with LIMS or other laboratory data management systems is preferred.
· 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); experience with statistical software is a plus.
· 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.
Benefits & Perks
· Competitive compensation
· Medical, Dental and Vision Insurance
· Business casual work attire
Compensation
· $33-$35 hourly rate dependent on experience
·Classification: Full-time, non-exempt