Analyst II

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

Analyst II

Full Time Technical Santa Ana, CA, Santa Ana, CA, US 1 Attachments

2 days ago Requisition ID: 1046

Salary Range: $33.00 To $35.00 Hourly

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.

• Medical, Dental and Vision Insurance
• Business casual work attire

Compensation:

• $33-$35 hourly rate dependent on experience

Attachments (1)

QC Analyst II, Quality Control_16JUL2026.docx