Quality Control Analyst-Bioassay (II,III)
NKGen Biotech is seeking a Quality Control Analyst to perform analytical (microbiological and environmental monitoring) testing in a cGMP environment.
- 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!