Quality Control Analyst II — Biotech GMP Lab

NKGen Biotech, Inc.; Santa Ana, Northern (CA, KY); Hybrid; USD 45,000 - 48,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Business casual work attire

Job summary

NKGen Biotech, Inc. is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment in Santa Ana, CA.

The role involves executing molecular biology, biochemical, microbiological, and physicochemical assays on materials and products to support GMP manufacturing. Ideal candidates have 2–4 years in a GMP QC lab, hands-on microbiology, and experience with LIMS and analytical techniques like flow cytometry or ELISA.

Qualifications

• Bachelor's degree in a life science (Biology, Chemistry or Biochemistry).
• 2–4 years of GMP-regulated QC laboratory experience in biotech/pharma.
• Hands-on microbiology techniques: aseptic technique, environmental monitoring, sterility testing, microbial culture.
• Experience with analytical techniques such as flow cytometry, ELISA, spectrophotometry or similar.
• Experience with LIMS or similar data management systems preferred.
• Knowledge of FDA, GLP, cGMP, ALCOA+ data integrity principles and lab documentation practices.
• Ability to perform routine lab testing and basic troubleshooting independently.
• Strong organization and the ability to manage multiple priorities and meet deadlines.
• Proficiency in Microsoft Office; statistical software a plus.
• Excellent verbal and written communication for cross-functional teams.
• Willingness to work in a fast-paced startup with potential weekend/overtime hours.
• Authorized to work in the United States and able to pass a background check.

Responsibilities

• Execute molecular biology, biochemical, microbiological, and physicochemical testing on raw materials, process samples, and final products.
• Perform incoming material inspection and release testing to verify quality specifications.
• Perform microbiological testing including environmental monitoring, sterility testing, plate reading, and documentation.
• Operate, maintain, and verify laboratory instrumentation and computerized systems (e.g., LIMS).
• Maintain QC inventory and coordinate replenishment of supplies and reagents.
• Follow aseptic techniques and gowning procedures in cleanroom environments.
• Review, document, and maintain laboratory records per SOPs and regulatory requirements.
• Author and revise SOPs, test methods, specifications, and technical docs.
• Support batch release, stability studies, investigations, CAPAs, and change controls.
• Collaborate with QA, Manufacturing, and cross-functional teams to resolve issues.

Skills

Organizational skills

Communication

MS Office

Analytical thinking

Independent troubleshooting

Education

Bachelor's degree in life sciences

Tools

LIMS

Flow cytometry

ELISA

Job description

NKGen Biotech, Inc. is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment in Santa Ana, CA.

The role involves executing molecular biology, biochemical, microbiological, and physicochemical assays on materials and products to support GMP manufacturing. Ideal candidates have 2–4 years in a GMP QC lab, hands-on microbiology, and experience with LIMS and analytical techniques like flow cytometry or ELISA.