Quality Control Analyst (II,III)

QCA · Santa Ana, California
Department QCA
Employment Type Full-Time
Minimum Experience Mid-level

Job Title
Quality Control Analyst-Bioassay (II,III)

Job Summary

NKGen Biotech is seeking a Quality Control Analyst to perform analytical (microbiological and environmental monitoring) testing in a cGMP environment. 

General Responsibilities:

  • Conduct microbiological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
  • Perform routine and non-routine environmental monitoring in all controlled, classified areas
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete testing in a timely and appropriate manner.
  • May maintain inventory/supplies necessary to conduct routine testing.
  • Act as liaison between various departments within the organization ensuring the flow of communication between groups
  • Performs equipment maintenance and calibrations as required.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • Compile data, analyze information and prepare reports to project teams                               
  • Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
  • Provide training to junior staff.
  • Perform special projects as requested by supervisor                                         
  • May perform other duties as assigned

Job Qualifications & Skills

  • Bachelor’s Degree in Microbiology, Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, or 3-7 years’ relevant experience, or Master’s degree in Chemistry, or Biological Sciences, with 3-5 years’ experience.
  • Candidates must be authorized to work in the U.S. and agree to a background check
  • Working knowledge of GMP quality systems, regulatory requirements, relevant Pharmacopeia and guidance documents.
  • Experience with Endotoxin, Direct inoculation Sterility Testing, gram staining, FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
  • Experience with setting up and successfully managing cell-based assays is highly preferred.
  • Education, training, or experience in cell therapy a plus.
  • Proficient in MS Office, Visio, Project, and statistical software.
  • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Shift and/or weekend work may be required

Benefits & Perks

  • Competitive compensation
  • Medical, Dental and Vision Insurance
  • Business casual work attire
  • Fully stocked kitchen and much more!



Thank You

Your application was submitted successfully.

  • Location
    Santa Ana, California
  • Department
  • Employment Type
  • Minimum Experience