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Quality Assurance Analyst II

2 months ago

Santa Ana, California, United States NKGen Biotech Full time
Quality Control Analyst at NKGen Biotech

NKGen Biotech is seeking a dedicated Quality Control Analyst to perform analytical evaluations within a cGMP framework.

Key Responsibilities:

  • Conduct biological, chemical, and physical assessments of raw materials, in-process, and final product samples to support manufacturing, validation, process development, and stability studies in a GMP setting.
  • Employ advanced laboratory instrumentation and software systems to gather and document data accurately.
  • Execute assays that require meticulous analytical capabilities and a solid understanding of biological and chemical principles.
  • Complete testing efficiently and within designated timelines.
  • May oversee inventory management and carry out equipment maintenance and calibration as necessary.
  • Perform aseptic sampling, visual inspections, gowning, and operate in cleanroom environments.
  • Review, modify, and compose test methods and standard operating procedures.
  • Ensure adherence to company SOPs, FDA regulations, GLP, QSR, and cGMP standards.
  • Investigate and document exceptions as needed.

Qualifications:

  • Bachelor's degree in Chemistry or Biological Sciences with relevant Analytical Chemistry/Laboratory coursework and 3-6 years of experience, or a Master's degree with 2-5 years of experience.
  • Familiarity with GMP quality systems, regulatory standards, and applicable pharmacopeia.
  • Experience with various testing methodologies including FACS, ELISAs, PCR, FTIR, UV, and Fluorescence spectroscopy.
  • Proficient in MS Office, Visio, Project, and statistical analysis software.
  • Ability to thrive in a dynamic, start-up environment while managing multiple tasks simultaneously.
  • Strong interpersonal skills with the capability to work both independently and collaboratively.
  • Availability for off-hours or weekend work may be necessary.

Benefits:

  • Competitive salary
  • Comprehensive Medical, Dental, and Vision Insurance
  • Business casual dress code
  • Fully stocked kitchen and additional perks