Quality Control Analyst

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

Job Title
Quality Control Analyst, Bioassay

 

Job Summary


 NKGen Biotech is seeking a Quality Control Analyst (Bioassay team) to perform bioanalytical testing in a cGMP environment. 

 

General Responsibilities

 

  • Conduct biological analyses of raw materials, in-process and final cell product to support manufacturing, validation, process development and stability studies in a GMP environment.
  • Perform bioanalytical cell-based assays with precise skills and understanding scientific principles.
  • Perform daily task such as Cell culture, flow cytometry, potency test, ELISA, qPCR, and visual inspection.
  • Complete testing in an appropriate and timely manner.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • 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.
  • Actively oversee laboratory supply inventory and manage purchasing for conducting routine tests.
  • Work closely with Facilities and Engineering to coordinate equipment maintenance and calibrations.
  • Provide mentorship to junior staff and supporting new employee onboarding.

 

*The company reserves the right to add or change duties at any time.

 

 

Job Qualifications & Skills

 

  • Bachelor’s Degree in Biology, Immunology, or other Life Science with 5+ yr experience
  • Master’s degree in Biology, Immunology, or other Life Science with 3+ yr experience
  • Extensive hands-on experience of Cell culture, Flow cytometry, ELISAs, qPCR, DNA isolation, and other applicable methods to the testing of biopharmaceuticals.
  • Experience in various cell-based assays is preferred.
  • Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia, and guidance documents.
  • Experience working with Smartsheet a plus.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Self-motivated and Comfortable in a fast-paced, start-up environment, while dealing with ambiguity.
  • Candidates must be authorized to work in the U.S. and agree to a background check.

 

Benefits & Perks

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

 

 

 

 

 

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