Biotech QC Analyst II — GMP Microbiology & Testing

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

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.