Analyst II

NKGen Biotech; Irvine (CA); On-site; 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 is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment in Santa Ana, CA. The role supports GMP manufacturing by executing multidisciplinary testing on raw materials, in-process samples, and final products.

The Analyst II will maintain instruments, document results, follow SOPs, and collaborate with QA and Manufacturing to resolve quality issues. Weekend/overtime flexibility is required in a fast-paced startup setting.

Qualifications

• Bachelor’s degree in life science or related field.
• 2–4 years of GMP-regulated QC laboratory experience in biotech/pharma.
• Hands-on microbiology, aseptic technique, and environmental monitoring.
• Experience with analytical techniques (flow cytometry, ELISA, spectrophotometry).
• Familiarity with data integrity, FDA/GLP/cGMP requirements, and LIMS.
• Strong documentation practices and ability to troubleshoot basic issues.
• Effective communication and cross-functional collaboration.
• Ability to work in fast-paced startup environment and handle overtime.

Responsibilities

• Execute molecular biology, biochemical, microbiological, and physicochemical testing on raw materials, in-process samples, and final products to support GMP manufacturing.
• Perform incoming material inspection and release testing to verify quality specifications.
• Perform microbiological testing including environmental monitoring and sterility testing; maintain records of results.
• Operate and maintain laboratory instrumentation and systems (e.g., LIMS) per GMP requirements.
• Maintain QC inventory and coordinate replenishment of supplies.
• Follow aseptic techniques and gowning procedures for cleanroom work.
• Review and maintain laboratory records per SOPs, FDA, GLP, cGMP, and data integrity rules.
• Author and update SOPs and test methods; support GMP operations and continuous improvement.
• Support batch release, stability studies, investigations, CAPAs, and change controls; collaborate with QA and Manufacturing.

Skills

GMP knowledge

Analytical testing

Environmental monitoring

Aseptic technique

Documentation

Troubleshooting

Team collaboration

Excel

Written communication

Time management

Education

Bachelor’s degree in life science

Tools

LIMS

Excel

PowerPoint

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Analyst II

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

10 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-function 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